Outlook Therapeutics (OTLK) 10-K 19 Dec 19 2019 FY Annual report Financial data

Document And Entity Information

Document And Entity Information - USD ($) $ in Millions	12 Months Ended
	Sep. 30, 2019	Dec. 16, 2019	Mar. 29, 2019
Document And Entity Information
Entity Registrant Name	Outlook Therapeutics, Inc.
Entity Central Index Key	0001649989
Trading Symbol	ons
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Voluntary Filers	No
Current Fiscal Year End Date	--09-30
Entity Shell Company	false
Entity Filer Category	Non-accelerated Filer
Entity Well-known Seasoned Issuer	No
Entity Public Float			$ 18.9
Entity Common Stock, Shares Outstanding		30,103,173
Document Type	10-K
Document Period End Date	Sep. 30, 2019
Amendment Flag	false
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	FY
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Current assets:
Cash	$ 8,015,528	$ 1,717,391
Prepaid and other current assets	4,986,033	1,585,089
Assets held for sale	500,000
Total current assets	13,501,561	3,302,480
Property and equipment, net	3,175,960	18,489,976
Other assets	457,476	491,039
Total assets	17,134,997	22,283,495
Current liabilities:
Convertible senior secured notes	6,699,000	13,179,449
Current portion of long-term debt	1,026,168	66,480
Current portion of capital lease obligations	192,290	520,794
Stockholder notes	3,612,500	4,612,500
Accounts payable	2,277,817	3,609,607
Accrued expenses	4,622,988	6,458,471
Income taxes payable	1,859,434	1,856,129
Deferred revenue		1,738,603
Total current liabilities	20,290,197	32,042,033
Long-term debt	50,285	98,487
Capital lease obligations	3,365,790	3,453,256
Warrant liability	255,734	1,227,225
Deferred revenue		2,758,262
Other liabilities	3,942,948	3,514,738
Total liabilities	27,904,954	43,094,001
Commitments (Note 9)
Convertible preferred stock:
Total convertible preferred stock	5,359,404	4,734,416
Stockholders' equity (deficit):
Common stock, par value $0.01 per share; 200,000,000 shares authorized; 28,609,995 and 9,027,491 shares issued and outstanding at September 30, 2019 and 2018, respectively	286,100	90,275
Additional paid-in capital	238,064,947	190,672,166
Accumulated deficit	(254,480,408)	(216,307,363)
Total stockholders' equity (deficit)	(16,129,361)	(25,544,922)
Total liabilities, convertible preferred stock and stockholders' equity (deficit)	17,134,997	22,283,495
Series A convertible preferred stock
Convertible preferred stock:
Total convertible preferred stock
Series A-1 convertible Preferred Stock
Convertible preferred stock:
Total convertible preferred stock	5,359,404	4,734,416
Series B convertible preferred stock
Stockholders' equity (deficit):
Preferred stock, value

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parentheticals) - $ / shares	Sep. 30, 2019	Sep. 30, 2018
Preferred stock, par value per share (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized	7,300,000	7,300,000
Preferred stock, shares issued	0	0
Preferred stock shares outstanding	0	0
Common stock, par value per share (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued	28,609,995	9,027,491
Common stock, shares outstanding	28,609,995	9,027,491
Series A convertible preferred stock
Convertible preferred stock, shares authorized	1,000,000	1,000,000
Convertible preferred stock, shares issued	0	0
Convertible preferred stock outstanding	0	0
Convertible stock, par value (in dollars per share)	$ 0.01	$ 0.01
Series A-1 convertible Preferred Stock
Convertible preferred stock, shares authorized	200,000	200,000
Convertible preferred stock, shares issued	66,451	60,203
Convertible preferred stock outstanding	66,451	60,203
Convertible stock, par value (in dollars per share)	$ 0.01	$ 0.01
Series B convertible preferred stock
Preferred stock, par value per share (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized	1,500,000	1,500,000
Preferred stock, shares issued	0	0
Preferred stock shares outstanding	0	0

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Consolidated Statements of Operations
Collaboration revenues	$ 8,146,123	$ 3,087,560
Operating expenses:
Research and development	23,805,251	18,504,035
General and administrative	9,369,823	14,227,828
Impairment of property and equipment	11,270,110	0
Total operating expenses	44,445,184	32,731,863
Loss from operations	(36,299,061)	(29,644,303)
Interest expense, net	3,466,688	3,891,250
Loss on extinguishment of debt	607,240	1,252,353
Change in fair value of warrant liability	(2,438,201)	(1,047,729)
Loss before income taxes	(37,934,788)	(33,740,177)
Income tax benefit	(3,411,001)	(3,648,216)
Net loss	(34,523,787)	(30,091,961)
Recognition of beneficial conversion feature upon issuance of Series A and A-1 convertible preferred stock	(61,365)	(16,022,963)
Series A and A-1 convertible preferred stock dividends and related settlement	(624,988)	(1,903,930)
Deemed dividend upon modification of warrants	(829,530)
Net loss attributable to common stockholders	$ (36,039,670)	$ (48,018,854)
Per share information:
Net loss per share of common stock, basic and diluted (in dollars per share)	$ (1.98)	$ (9.74)
Weighted average shares outstanding, basic and diluted (in shares)	18,191,827	4,932,202

Consolidated Statements of Conv

Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($)	Series A-1 convertible Preferred Stock	Series A convertible preferred stock	Series B convertible preferred stock	Common stock repurchase note	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Sep. 30, 2017		$ 2,924,441		$ 31,167	$ 152,533,260	$ (186,215,402)	$ (33,650,975)
Balance (in shares) at Sep. 30, 2017		32,628		3,116,692
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Proceeds from exercise of common stock warrants				$ 4	(4)
Proceeds from exercise of common stock warrants (in shares)				432
Conversion of Series A convertible preferred stock into Series A-1 convertible preferred stock	$ 4,587,579	$ (4,587,579)
Series A convertible preferred stock dividends and related settlement		(1,757,093)			(1,740,108)		(1,740,108)
Conversion of Series A convertible preferred stock into common stock		$ (14,359,816)		$ 39,466	14,320,350		14,359,816
Conversion of Series A convertible preferred stock into common stock (in shares)		(208,836)		3,946,577
Private placement sale of common stock and common stock warrants, net of costs				$ 15,943	14,679,177		14,695,120
Series A-1 convertible preferred stock dividends and related settlement	$ 146,837				(146,837)		(146,837)
Conversion of Series B convertible preferred stock into common stock			$ (2,661,972)	2,641	2,659,331
Conversion of senior secured notes into Series B convertible preferred stock			$ 2,661,972				2,661,972
Conversion of senior secured notes into Series B convertible preferred stock (in shares)			1,500,000
Issuance of vested restricted stock units				$ 1,054	(1,054)
Issuance of vested restricted stock units (in shares)				105,361
Series A and A-1 convertible preferred stock dividends and related settlement (in shares)		17,571
Series A-1 convertible preferred stock dividends and related settlement (in shares)	1,468
Stock-based compensation expense					1,985,870		1,985,870
Conversion of Series B convertible preferred stock into common stock (in shares)			(1,500,000)	264,084
Conversion of Series A convertible preferred stock into Series A-1 convertible preferred stock (in shares)	58,735	(58,735)
Sale of Series A convertible preferred stock and common stock warrants, net of costs		$ 14,265,861			6,382,181		6,382,181
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)		217,372		1,594,345
Net loss						(30,091,961)	(30,091,961)
Balance at Sep. 30, 2018	$ 4,734,416			$ 90,275	190,672,166	(216,307,363)	(25,544,922)
Balance (in shares) at Sep. 30, 2018	60,203			9,027,491
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Conversion of Series A convertible preferred stock into common stock				$ 503	401,464		401,967
Conversion of Series A convertible preferred stock into common stock (in shares)				50,394
Private placement sale of common stock and common stock warrants, net of costs				$ 26,804	19,781,514		19,808,318
Private placement sale of common stock and common stock warrants, net of costs (in shares)				2,680,390
Series A-1 convertible preferred stock dividends and related settlement	$ 624,988				(624,988)		(624,988)
Issuance of common stock in connection with exercise of warrants				$ 61,348	(56,998)		4,350
Issuance of common stock in connection with exercise of warrants (in shares)				6,134,763
Issuance of vested restricted stock units				$ 41	(41)
Issuance of vested restricted stock units (in shares)				4,069
Issuance of common stock in connection with conversion of stockholder notes				$ 3,729	476,271		480,000
Issuance of common stock in connection with conversion of stockholder notes (in shares)				372,888
Series A and A-1 convertible preferred stock dividends and related settlement (in shares)	6,248
Stock-based compensation expense					1,313,335		1,313,335
Sale of Series A convertible preferred stock and common stock warrants, net of costs				$ 103,400	26,053,103		$ 26,156,503
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)				10,340,000			2,680,390
Accrued directors fees settled in fully vested stock options					49,121		$ 49,121
Net loss						(34,523,787)	(34,523,787)
Balance at Sep. 30, 2019	$ 5,359,404			$ 286,100	$ 238,064,947	(254,480,408)	(16,129,361)
Balance (in shares) at Sep. 30, 2019	66,451			28,609,995
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Cumulative effect of adoption of ASU 2014-09 (Topic 606)						$ (3,649,258)	$ (3,649,258)

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
OPERATING ACTIVITIES
Net loss	$ (34,523,787)	$ (30,091,961)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	3,361,873	3,054,352
Loss on extinguishment of debt	607,240	1,252,353
Non-cash interest expense	1,314,321	1,315,861
Stock-based compensation	1,313,335	1,985,870
Change in fair value of warrant liability	(2,438,201)	(1,047,729)
Impairment of property and equipment	11,270,110	0
Loss on lease termination		4,173,682
Changes in operating assets and liabilities:
Prepaid and other current assets	(3,245,146)	(1,419,551)
Other assets	(87,182)	1,554
Accounts payable	(1,331,640)	(6,714,137)
Accrued expenses	(482,665)	(1,664,843)
Income taxes payable	3,305	(496,000)
Deferred revenue	(8,146,123)	(3,057,561)
Other liabilities	94,572	(331,413)
Net cash used in operating activities	(32,289,988)	(33,039,523)
INVESTING ACTIVITIES
Purchase of property and equipment	(437,307)	(2,781,125)
Net cash used in investing activities	(437,307)	(2,781,125)
FINANCING ACTIVITIES
Proceeds from issuance of common stock through private placement and public offering, net	45,964,821	14,695,120
Proceeds from issuance of Series A convertible preferred stock		21,737,200
Proceeds from exercise of common stock warrants	4,350
Payments of capital leases obligations	(526,087)	(862,906)
Repayment of debt	(6,417,652)	(127,736)
Payment of financing costs		(1,089,158)
Net cash provided by financing activities	39,025,432	34,352,520
Net increase (decrease) in cash	6,298,137	(1,468,128)
Cash at beginning of year	1,717,391	3,185,519
Cash at end of year	8,015,528	1,717,391
Supplemental disclosure of cash flow information
Cash paid for interest	2,794,572	109,979
Supplemental schedule of noncash investing activities:
Purchases of property and equipment in accounts payable and accrued expenses		816,501
Supplemental schedule of noncash financing activities:
Senior secured notes and accrued interest converted into common stock	401,967
Unsecured notes and accrued interest converted into common stock	480,000
Issuance of Series B convertible preferred stock upon conversion of senior secured notes, net of unamortized debt discount		1,409,619
Issuance of capital lease obligations in connection with purchase of property and equipment	48,683	4,444,095
Change in fair value of convertible senior secured notes warrants capitalized as deferred financing costs	1,466,710
Series A and A-1 convertible preferred stock dividends	624,988	1,886,945
Settlement of Series A and A-1 convertible preferred stock dividends upon issuance of Series A and A-1 convertible preferred stock	624,988	$ 1,903,930
Accrued directors fees settled in fully vested stock options	$ 49,121

Organization and Operations

Organization and Operations	12 Months Ended
	Sep. 30, 2019
Organization and Operations
Organization and Operations	1. Organization and Operations Description of the Business Outlook Therapeutics, Inc., (formerly Oncobiologics, Inc.), ("Outlook" or the "Company") was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc." in November 2018. The Company is a late clinical-stage biopharmaceutical company focused on developing and commercializing ONS‑5010, an ophthalmic formulation of bevacizumab for use in retinal indications. The Company is based in Cranbury, New Jersey.

Liquidity

Liquidity	12 Months Ended
	Sep. 30, 2019
Liquidity
Liquidity	2. Liquidity The Company has incurred substantial losses and negative cash flows from operations since its inception and has a stockholders’ deficit of $16.1 million as of September 30, 2019. As of September 30, 2019, the Company had substantial indebtedness that included $6.7 million of convertible senior secured notes that mature on December 22, 2019, $3.6 million of unsecured notes that are due on demand, and $1.0 million of unsecured notes that were due on demand, but which are subject to a forbearance agreement through March 7, 2020. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. In September 2019, the holder of $1.0 million of outstanding principal and accrued interest of the Company’s unsecured notes began exchanging the outstanding principal and accrued interest from those notes for the Company’s common stock per the terms of a forbearance agreement dated March 7, 2019. The holder exchanged the remaining $1.5 million of accrued interest and principal for an aggregate 1,475,258 shares of the Company’s common stock between October 1, 2019 and December 5, 2019. On December 11, 2019, the Company received approval from the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer Program to sell approximately $3.6 million of its unused New Jersey net operating losses (“NOLs”) and research and development tax credits (“R&D credits”). The Company expects to receive approximately $3.3 million of proceeds from the sale of the New Jersey NOLs and R&D credits. Management believes that the Company’s existing cash as of September 30, 2019 and anticipated proceeds from the sale of New Jersey NOLs and R&D credits will be sufficient to fund its operations into March 2020, excluding any unscheduled repayment of debt. Substantial additional financing will be needed by the Company to fund its operations in the future and to commercially develop its product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include, but are not limited to: payments from potential strategic research and development partners, licensing and/or marketing arrangements with pharmaceutical companies, private placements of equity and/or debt securities, sale of its development stage product candidates to third parties and public offerings of equity and/or debt securities. There can be no assurance that these future funding efforts will be successful. The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to complete revenue-generating partnerships with pharmaceutical companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies, and, ultimately; (v) regulatory approval and market acceptance of the Company’s proposed future products.

Basis of Presentation and Summa

Basis of Presentation and Summary of Significant Accounting Policies	12 Months Ended
	Sep. 30, 2019
Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation and Summary of Significant Accounting Policies	3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statement of operations as they occur. Reverse stock-split On March 15, 2019, the Company amended its amended and restated certificate of incorporation to implement a one-for-eight reverse stock split of its common stock. As a result of the reverse stock split, the Company adjusted the share amounts under its employee incentive plans, outstanding options, restricted stock units and common stock warrant agreements with third parties. The disclosure of common shares and per common share data in the accompanying consolidated financial statements and related notes reflect the reverse stock split for all periods presented. Use of estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary. Fair value of financial instruments At September 30, 2019 and 2018, the Company’s financial instruments included cash, accounts payable, accrued expenses, equipment loans, stockholder notes and senior secured debt. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments. Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the life of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations. Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. The Company recognized an impairment loss of $11.3 million for the year ended September 30, 2019 which is described more fully in Note 5. There was no impairment charge recognized during the year ended September 30, 2018. Stock-based compensation The Company measures equity classified stock-based awards granted to employees and directors based on the estimated fair value on the date of grant and recognizes compensation expense of those awards, on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in Note 12. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant. Stock-based awards granted to consultants and non-employees are measured based on the fair value of the award on the date on which the related services are completed. Compensation expense is recognized over the period during which services are rendered by such consultants and non-employees until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option-pricing model. The Company accounts for forfeitures of stock option awards as they occur. Revenue recognition On October 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) and changed its revenue recognition policies accordingly. The standard’s stated core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about: · Contracts with customers – including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations). · Significant judgments and changes in judgments – determining the timing of satisfaction of performance obligations (over time or at a point in time) and determining the transaction price and amounts allocated to performance obligations. · Certain assets  – assets recognized from the costs to obtain or fulfill a contract. The Company’s revenue is generated primarily through collaboration research and license agreements. The terms of these agreements generally contain multiple deliverables which may include (i) licenses, (ii) research and development activities, (iii) clinical manufacturing and, (iv) product supply. The payment terms of these agreements may include nonrefundable upfront fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. The Company typically receives upfront, nonrefundable payments when licensing its intellectual property. The Company’s arrangements fall under ASC 808, Collaborations (“ASC 808”). ASC 808 does not address recognition or measurement matters but prescribes that entities look to other GAAP by analogy, namely ASU 2014-09. As such, the Company completed an analysis of existing contracts with the Company’s collaboration partners and assessed the differences in accounting for such contracts under ASU 2014-09 compared with current revenue accounting standards. Under the ASU 2014-09, the Company treat substantive milestones as forms of variable consideration which is recognized over the estimated performance period. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. The Company adopted the new accounting standard utilizing the modified retrospective method, and, therefore, no adjustments were made to amounts in its prior period financial statements. The Company recorded the cumulative effect of adopting the standard as an adjustment to increase accumulated deficit by $3.6 million. During the fiscal year ended September 30, 2019, we would have recognized $4.5 million of collaboration revenues under revenue recognition guidance in effect during fiscal 2018 prior to the adoption of ASU 2014-09. Incentive and tax receivables The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable period. The Company’s estimate of the amount of cash refund it expects to receive related to the Australian research and development tax incentive program is included in prepaid and other current assets in the accompanying consolidated balance sheets. As of September 30, 2019, the Company’s estimate of the amount of cash refund it expects to receive in 2020 for 2019 eligible spending as part of this incentive program was $1.1 million. As of September 30, 2018, the Company had a receivable of $0.3 million which was received in 2019 as part of this incentive program. In addition, the Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in prepaid and other current assets in the accompanying consolidated balance sheet. As of September 30, 2019, and 2018, prepaid and other current assets included $0.1 million for refundable GST on expenses incurred with Australian vendors. Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the years ended September 30, 2019 and 2018, the Company recorded $1.2 million and $0.3 million, respectively, in its consolidated statements of operations related to the cash refund it expected to receive from the Australian research and development tax incentive program. Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Net loss per share Basic net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2019 and 2018, as they would be antidilutive: September 30, 2019 2018 Series A‑1 convertible preferred stock 1,255,789 1,137,714 Convertible senior secured notes 767,605 — Convertible unsecured notes 149,573 — Performance-based stock units 15,691 16,131 Restricted stock units 109 7,638 Stock options 1,389,999 182,120 Common stock warrants 16,067,948 5,661,506 Recently issued accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASC 842”). The FASB issued subsequent amendments to the initial guidance in July 2018 with ASU 2018-10 and in August 2018 with ASU 2018-11. ASC 842 supersedes the current accounting for leases. The new standard requires lessees to record a right of use asset and a related liability for the rights and obligations associated with a lease, regardless of lease classification, and eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. The Company adopted the new standard on October 1, 2019 using a modified retrospective approach, the transition method that allows for application of the standard at the adoption date rather than at the beginning of the earliest comparative period presented in the financial statements. The Company also elected available practical expedients. While the Company is still finalizing its adoption procedures, the Company estimates the primary impact to the consolidated financial position upon adoption will be the recognition, on a discounted basis, of the minimum commitments under noncancelable operating leases on the consolidated balance sheets resulting in the recording of lease obligations for approximately $0.4 million. The adoption of the guidance will not impact the Company’s consolidated statements of operations or cash flows. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which removes and modifies some existing disclosure requirements and adds others. ASU 2018-13 modifies the disclosure requirements for fair value measurements and removes the requirement to disclose (1) the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, (2) the policy for timing of transfers between levels, and (3) the valuation processes for Level 3 fair value measurements. ASU 2018-13 requires disclosure of changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The ASU is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. Early adoption is permitted for any eliminated or modified disclosures upon issuance of this ASU. The Company is currently evaluating the impact of the adoption of this standard.

Fair Value Measurements

Fair Value Measurements	12 Months Ended
	Sep. 30, 2019
Fair Value Measurements
Fair Value Measurements	4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: · Level 1 — Quoted prices in active markets for identical assets or liabilities. · Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis: September 30, 2019 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 255,734 September 30, 2018 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 1,227,225 The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability for the years ended September 30, 2019 and 2018: Balance at October 1, 2017 $ 2,274,954 Change in fair value (1,047,729) Balance at September 30, 2018 1,227,225 Senior note warrants modification 1,466,710 (i) Change in fair value (2,438,201) Balance at September 30, 2019 $ 255,734 (i) The Senior Note Warrants issued in connection with the senior secured notes (see Note 8) are classified as liabilities on the accompanying consolidated balance sheets as the Senior Note Warrants include cash settlement features at the option of the holders under certain circumstances. The warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair value of the warrant liability is estimated using the Black-Scholes option pricing model using the following assumptions: September 30, 2019 2018 Risk-free interest rate 1.56% 2.90% Remaining contractual life of warrant 5.38 years 3.39 years Expected volatility 89% 82% Annual dividend yield 0% 0% Fair value of common stock $ 1.49 per share $ 7.84 per share

Property and Equipment, Net

Property and Equipment, Net	12 Months Ended
	Sep. 30, 2019
Property and Equipment, Net
Property and Equipment, Net	5. Property and Equipment Property and equipment, net, consists of: September 30, 2019 2018 Laboratory equipment $ 1,067,351 $ 14,333,624 Leasehold improvements 160,086 10,095,100 Computer software and hardware — 483,807 Land and building 3,000,000 3,000,000 Construction in progress — 2,276,737 4,227,437 30,189,268 Less: accumulated depreciation and amortization (1,051,477) (11,699,292) $ 3,175,960 $ 18,489,976 Depreciation and amortization expense for the years ended September 30, 2019 and 2018 was $3,361,873 and $3,054,351, respectively. At September 30, 2019, $3,000,000 and at September 30, 2018, $7,953,856 represents laboratory equipment under capital leases and the Company’s corporate office that is classified as a capital lease. At September 30, 2019 and September 30, 2018, $475,000 and $1,619,741, respectively, of accumulated amortization related to capital leases. The term of the equipment leases were between 22 and 36 months and qualify as capital leases. The equipment leases bear interest between 5.0% and 19.4% and the effective interest rate on the corporate office lease is 43.9%. Impairment Charge During the year ended September 30, 2019, the Company wrote off certain construction in progress and laboratory equipment with a carrying amount of $1,913,798 due to the Company changing its operations to focus solely on developing and commercializing ONS-5010. The Company determined that the carrying amount of these assets was not recoverable. In the fourth quarter of fiscal year 2019, as a result of management’s decision to outsource the commercial manufacturing and remaining development for the Company’s ONS-5010 program, the Company decided to vacate and sublease the Company’s manufacturing and corporate offices and sell or transfer excess laboratory and related computer equipment no longer required for the development of the Company’s ONS-5010 program. These events qualified as indicators of impairment in accordance with ASC 360, Property, Plant and Equipment (“ASC 360”) and required an impairment analysis. As a result of the analysis, management determined that the Company’s long-lived assets with a carrying amount of $13,032,320 were no longer recoverable and were impaired and wrote the assets down to their estimated fair value of $3,676,008. The estimated fair value for the Company’s land and building and leasehold improvement assets was based on discounted expected future cash flows using Level 3 inputs under ASC 820, Fair Value Measurements (“ASC 820”). The estimated fair value for the Company’s laboratory and related computer equipment was based on offers the Company received from unrelated third parties to purchase the assets which is classified as a Level 3 measurement under ASC 820’s fair value hierarchy. Management determined that $500,000 of laboratory equipment met the definition of “held for sale” under ASC 360 as it was probable that a sale of the laboratory equipment could be completed within one year as of September 30, 2019. The Company recorded an impairment charge totaling $11,270,110 for the year ended September 30, 2019 in the consolidated statements of operations associated with the above items. Corporate Office Lease In February 2018, the Company entered into a sixth amendment to its lease for its corporate offices. Pursuant to the amended terms, the Company is now occupying 100% of the corporate facility and has extended the term through February 2028 with two five - year renewal options. As a result of this amendment, the lease became classified as a capital lease. The Company initially recorded the lease obligation and corresponding building asset based on its estimated fair value of $3,000,000. The building is being depreciated over the lease term. Future lease payments will be allocated to interest expense and a pay-down of the lease obligation. During the years ended September 30, 2019 and 2018, the Company recorded interest expense of $1,425,913 and $823,592, respectively. The following is a schedule of future minimum lease payments under capital leases as of September 30, 2019 for the years ending September 30: 2020 $ 1,608,067 2021 1,506,592 2022 1,535,809 2023 1,564,027 2024 1,593,291 Thereafter 5,691,492 13,499,278 Less: amounts representing interest (9,941,198) Less: current portion (192,290) Capital lease obligations, excluding current portion $ 3,365,790

Accrued Expenses

Accrued Expenses	12 Months Ended
	Sep. 30, 2019
Accrued Expenses
Accrued expenses	6. Accrued Expenses Accrued expenses consists of: September 30, 2019 2018 Compensation $ 919,394 $ 2,231,122 Severance and related costs 505,570 396,138 Research and development 1,692,040 1,065,169 Interest payable 934,145 1,991,044 Professional fees 419,216 313,585 Director fees — 59,122 Other accrued expenses 152,623 402,291 $ 4,622,988 $ 6,458,471

Stockholder Notes

Stockholder Notes	12 Months Ended
	Sep. 30, 2019
Stockholder Notes
Stockholder Notes	7. Stockholder Notes September 30, 2019 2018 Restricted stock repurchase notes $ 800,000 $ 800,000 Common stock repurchase note 2,812,500 2,812,500 Working capital notes — 1,000,000 3,612,500 4,612,500 Less: current portion (3,612,500) (4,612,500) $ — $ — The Company previously repurchased shares of its restricted stock in exchange for notes that bear interest at rates ranging from 0% to 4% per annum and are due on demand. The Company has a $2,812,500 note payable related to the previous repurchase of common stock that does not bear interest and is due on demand. The Company also borrowed from stockholders for working capital purposes and had outstanding two unsecured stockholder notes having an original aggregate principal amount of $1,000,000 and which bear interest from 0% to 30% per annum. The notes are due on demand but are currently subject to a forbearance through March 7, 2020 pursuant to a forbearance and exchange agreement dated March 7, 2019 with a different lender. The holder of these notes agreed to refrain and forbear from bringing any action to collect under the stockholder notes until March 7, 2020 and to reduce the interest rates currently in effect to 12.0% per annum simple interest during such forbearance period. The Company also agreed to repay or exchange the unsecured stockholder notes (or portions thereof) during the forbearance period for shares of the Company’s common stock at an exchange rate of $13.44 per share or, beginning September 2019, at 95% of the average of the two lowest closing bid prices in the prior twenty trading days, as applicable. The forbearance and exchange agreement was accounted for as an extinguishment of debt and the Company recorded a loss of $183,554 during the year ended September 30, 2019. During the year ended September 30, 2019, unsecured notes with a carrying amount of $ $22,034 and accrued interest of $457,966 were exchanged for 372,888 shares of the Company’s common stock at weighted average exchange price of $1.29. As of September 30, 2019, the unsecured stockholder notes are included in the current portion of long-term debt on consolidated balance sheets. During the years ended September 30, 2019 and 2018, the Company recognized interest expense related to the stockholder notes of $105,357 and $300,000, respectively.

Debt

Debt	12 Months Ended
	Sep. 30, 2019
Debt
Debt	8. Debt Senior secured notes September 30, 2019 2018 Convertible senior secured notes $ 6,699,000 $ 13,500,000 Unamortized debt discount — (320,551) $ 6,699,000 $ 13,179,449 In October 2017, the Company exchanged $1.5 million aggregate principal amount of senior secured notes and $41,507 of accrued interest for 1,500,000 shares of Series B convertible preferred stock (“Series B Convertible”). The Company recognized a loss on extinguishment of $1,252,353 in connection with the exchange and represents the excess fair value of the Series B Convertible issued over the net carrying amount of the debt and accrued interest. In November 2018, the Company reached an agreement with the holders of its $13.5 million senior secured notes to extend the maturity of the senior secured notes until December 22, 2019, in exchange for making several payments of principal and interest during 2019, as well as subject to meeting additional capital raising commitments that the Company met in April 2019 through the completed public offering. In addition, the Company agreed to make the senior secured notes convertible into common stock at a price of $8.9539 per share and reduced the exercise price of warrants to purchase 485,245 shares of common stock held by the senior secured noteholders from $24.00 per share to $12.00 per share. The increase in the fair value of the warrants of $1.5 million due to the modification was recorded as additional debt discount and amortized over the remaining term of the senior secured notes using the effective interest rate method. The total amortization of the debt discount for the year ended September 30, 2019 was $1,314,321. During the year ended September 30, 2019, convertible senior secured notes with a carrying amount of $400,575 and accrued interest of $1,393 were converted into 50,394 shares of the Company’s common stock. During the year ended September 30, 2019, the Company repaid a total of $6.4 million of principal and $1.3 million of accrued interest of such notes. In June 2019, the Company entered into a Third Note Amendment (the “Third Amendment”) with the holders of the remaining $6.7 million outstanding aggregate principal amount of senior secured notes. Under the Third Amendment, the maturity date of the convertible senior secured notes was amended to December 22, 2019 and eliminated the scheduled payments of certain principal and interest payments on or prior to December 22, 2019. The Company also agreed to increase the interest rate payable on such convertible senior secured notes to 12.0% per annum from 5.0% per annum. The Third Amendment was accounted for as an extinguishment of debt. Loss on extinguishment of convertible senior secured notes recognized during the year ended September 30, 2019 was $423,686. Interest expense on the convertible senior secured notes for the years ended September 30, 2019 and 2018 was $1,892,155 and $1,997,231, respectively. Other indebtedness In addition to the Notes, the Company has other outstanding debt consisting of equipment loans and unsecured notes. Refer to Note 7 for additional information on unsecured notes (working capital notes). September 30, 2019 2018 Unsecured notes $ 977,966 $ — Equipment loans 98,487 164,967 1,076,453 164,967 Less: current portion (1,026,168) (66,480) Long-term debt $ 50,285 $ 98,487 The equipment loans bear interest at rates ranging from 12% to 16% with the original term of the loans ranging from 1 to 5 years. Minimum monthly payments of principal and interest under the equipment loans are collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and former chief executive officer. Interest expense on unsecured notes and equipment loans for the years ended September 30, 2019 and 2018 was $83,963 and $27,660, respectively. Future maturities of other indebtedness at September 30, 2019 are as follows for the years ending September 30: 2020 $ 1,026,168 2021 50,285 $ 1,076,453

Commitments

Commitments	12 Months Ended
	Sep. 30, 2019
Commitments
Commitments	9. Commitments Selexis Commercial License Agreements In April 2013, the Company entered into commercial license agreements with Selexis for each of the ONS‑3010, ONS‑1045 and ONS‑1050 biosimilar product candidates (which agreements were subsequently amended on May 21, 2014). Under the terms of each commercial license agreement, the Company acquired a non-exclusive worldwide license under the Selexis Technology to use the applicable Selexis expression technology along with the resulting Selexis materials/cell lines, each developed under the research license, to manufacture and commercialize licensed and final products, with a limited right to sublicense. The Company paid an upfront licensing fee to Selexis for each commercial license and also agreed to pay a fixed milestone payment for each licensed product. In addition, the Company is required to pay a low single-digit royalty on a final product-by-final product and country-by-country basis, based on worldwide net sales of such final products by the Company or any of the Company’s affiliates or sublicensees during the royalty term. The royalty term for each final product in each country is the period commencing from the first commercial sale of the applicable final product in the applicable country and ending on the expiration of the specified patent coverage. At any time during the term, the Company has the right to terminate its royalty payment obligation by providing written notice to Selexis and paying Selexis a royalty termination fee. Each of the Company’s commercial agreements with Selexis will expire upon the expiration of all applicable Selexis patent rights. Either party may terminate the related agreement in the event of an uncured material breach by the other party or in the event the other party becomes subject to specified bankruptcy, winding up or similar circumstances. Either party may also terminate the related agreement under designated circumstances if the Selexis Technology infringes third-party intellectual property rights. In addition, the Company has the right to terminate each of the commercial agreements at any time at its convenience; however, with respect to the agreements relating to ONS‑3010 and ONS‑1045, this right is subject to the licensee’s consent pursuant to a corresponding letter the Company executed in conjunction with the standby agreement entered into between Selexis and Laboratories Liomont, S.A. de C.V. (“Liomont”) in November 2014. The standby agreement permits Liomont to assume the license under the applicable commercial agreement for Mexico upon specified triggering events involving the Company’s bankruptcy, insolvency or similar circumstances. Technology license The Company entered into a technology license agreement with Selexis that will require milestone payments of $353,600 (based on an exchange rate on September 30, 2019 for converting Swiss Francs to U.S. dollars) to the licensor by the Company upon achievement of certain clinical milestones and pay a single digit royalty on net sales by the Company utilizing such technology. The Company also has the contractual right to buy out the royalty payments at a future date. Leases In August 2018, the Company entered into a lease termination agreement effective September 1, 2018, to terminate the lease for office and laboratory space in Cranbury, New Jersey which was due to expire in March 2026. In consideration for the termination of the lease, the Company agreed to make payments to the landlord totaling up to $5.8 million, which includes (i) $287,615 upon execution of the termination agreement, (ii) $50,000 per month for up to 30 months, commencing September 1, 2018, and (iii) a $4.0 million payment, in any event, on or before February 1, 2021. The Company and landlord agreed that the $174,250 security deposit will be used to pay the 7 th , 8 th , 9 th and a portion of the 10 th monthly payments. The Company may pay the final $4.0 million payment at any time, whereupon the Company’s obligation to make the remaining monthly payments terminates. In connection with the lease termination, the Company recorded a $4.2 million liability at September 1, 2018, the cease-use date that represents the present value of the future termination payments. The Company derecognized the assets and liabilities associated with the financing lease and recorded a charge of $4.2 million to general and administrative expense. At September 30, 2019 and 2018, the lease termination obligation is included in other liabilities on the consolidated balance sheet. A rollforward of the charges incurred to general and administrative expense for the years ended September 30, 2019 and 2018 is as follows: Balance Balance Expensed / Cash September 30, October 1, 2018 Accrued Expense Payments 2019 Lease termination payments $ 3,850,081 $ 485,117 $ (425,750) $ 3,909,448 Balance Expensed / Balance October 1, 2017 Accrued Expense Cash Payments September 30, 2018 Lease termination payments $ — $ 4,187,696 $ (337,615) $ 3,850,081 Derecognition of assets and liabilities — (14,014) — — $ — $ 4,173,682 $ (337,615) $ 3,850,081 Rent expense under operating leases was $1,139,714 and $854,487 for the years ended September 30, 2019 and 2018, respectively. The Company recognizes rent expense on a straight-line basis over the lease period and has accrued for rent expense incurred but not yet paid. Landlord allowances for tenant improvements are deferred and recognized as a reduction to rent expense on a straight-line basis and over the remaining lease term. Future minimum payments under noncancelable operating leases at September 30, 2019 are as follows for the years ending September 30: Operating Leases 2020 $ 187,500 2021 195,000 $ 382,500 Employee Benefit Plan The Company maintains a defined contribution 401(k) plan in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company matches 100% of the first 3% of employee contributions. The Company assumes all administrative costs of the Plan. For the years ended September 30, 2019 and 2018, the expense relating to the matching contribution was $125,828 and $175,693, respectively.

Stockholders' Equity (Deficit)

Stockholders' Equity (Deficit)	12 Months Ended
	Sep. 30, 2019
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit)	10. Stockholders’ Equity (Deficit) Common stock During the year ended September 30, 2019, the Company issued an aggregate of 2,680,390 shares of the Company’s common stock for gross cash proceeds of $20.0 million ($19.8 million net of issuance costs) pursuant to the November 5, 2018 BioLexis private placement agreement. In April 2019, the Company issued an aggregate of 10,340,000 shares of its common stock, 15-month warrants to purchase up to an aggregate of 10,340,000 shares of common stock and five-year warrants to purchase up to an aggregate of 10,340,000 shares of common stock for $26.2 million in net proceeds after payment of fees, expenses and underwriting discounts and commissions. The shares of common stock and the warrants were immediately separable and were issued separately. The warrants are exercisable immediately at an exercise price of $2.90 per share. During the year ended September 30, 2019 and 2018, the Company issued 4,069 and 105,361 shares of common stock, respectively, upon the vesting of RSUs. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Subject to preferences that may apply to any outstanding preferred stock, holders of common stock are entitled to receive ratably any dividends that the Company’s board of directors may declare out of funds legally available for that purpose on a non-cumulative basis. No dividends had been declared through September 30, 2019. Common stock warrants As of September 30, 2019, the Company had the following warrants outstanding to acquire shares of its common stock: Shares of common stock issuable upon Expiration Date exercise of warrants Exercise Price November 11, 2019 99,935 $ July 12, 2020 68,250 $ February 18, 2022 416,666 $ (i) April 24, 2024 10,340,000 $ December 22, 2024 277,122 $ (ii) April 13, 2025 145,686 $ (ii) May 31, 2025 62,437 $ (ii) October 31, 2025 2,093,750 $ May 10, 2026 1,282,051 $ June 8, 2026 1,282,051 $ 16,067,948 (i) In January 2019, the Company reduced the exercise price of these warrants from $52.80 to $12.00 and further extended the exercise period from February 18, 2019 to February 18, 2022. (ii) In November 2018, the Company reduced the exercise price of the warrants issued in connection with its senior secured notes from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. During the year ended September 30, 2019, warrants to purchase an aggregate of 10,273,558 shares of common stock with a weighted averaged exercise price of $2.90 were exercised resulting in the issuance of an aggregate 6,134,763 shares of the Company’s common stock. Of these exercised warrants, 10,270,250 of them were 15-month warrants issued in the Company’s April 2019 public offering that were exercised pursuant to the net exercise provisions therein. During the year ended September 30, 2018, warrants to purchase 432 shares with exercise prices of $0.08 were exercised.

Convertible Preferred Stock

Convertible Preferred Stock	12 Months Ended
	Sep. 30, 2019
Convertible Preferred Stock
Convertible Preferred Stock	11. Convertible Preferred Stock Series A Convertible Preferred Stock In September 2017, the Company entered into a purchase agreement with BioLexis, pursuant to which BioLexis agreed to purchase, in a private placement (the “Initial Private Placement”), $25.0 million of the Company’s newly-created voting Series A Convertible Preferred Stock (the “Series A Convertible”), and warrants (the “BioLexis Warrants”) to acquire 2,093,750 shares of common stock. In September 2017, the Company completed the initial sale of 32,628 shares of Series A Convertible to BioLexis for $3,262,800 in cash. In October 2017, the Company completed the sale of the remaining 217,372 shares of Series A Convertible and the BioLexis Warrants to BioLexis in the Initial Private Placement, for $21,737,200 in cash. The Series A Convertible was initially convertible into 4,724,493 shares of the Company’s common stock, representing an effective conversion rate of $5.28 per share, which represented a discount to the market value of the Company’s common stock as of September 7, 2017 and October 31, 2017 (on which dates, the closing price of the Company’s common stock was $7.20 and $10.08 per share, respectively). In connection with the second closing of the Series A Convertible in October 2017, the Company issued the BioLexis Warrants, which have a term of 8‑years and an initial exercise price of $7.20 per share. The proceeds from the second closing of the Series A Convertible were allocated among the Series A Convertible and the BioLexis Warrants based on their relative fair values. As a result of the discount to the market value and the allocation of a portion of the proceeds to the BioLexis Warrants, the Company recognized a beneficial conversion charge of $15,355,019, which represents the in-the-money value of the conversion rate as of the date of sale. The Series A Convertible accrued dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A Convertible, although the initial dividends payable on the shares of Series A Convertible issued in September 2017, while accruing from issuance, was payable in December 2017. The Series A Convertible was also entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of common stock or other securities. The initial conversion rate was subject to appropriate adjustment in the event of a stock split, stock dividend, combination, reclassification or other recapitalization affecting the common stock. During the year ended September 30, 2018, the Company issued an additional 17,571 shares of Series A Convertible to settle the related dividends that were due on a quarterly basis. The Company recognized a beneficial conversion charge of $597,255 during the year ended September 30, 2018, which represents the in-the-money value of the conversion rate as of the date of issuance. In June 2018, BioLexis converted 208,836 shares of Series A Convertible into 3,946,577 shares of common stock, and in July 2018 exchanged its remaining shares of Series A Convertible for newly created Series A‑1 (as defined below). As of such exchange, there were no longer any shares of Series A Convertible issued and outstanding. Series A‑1 Convertible Preferred Stock In July 2018, the Company entered into an exchange agreement (the “Exchange Agreement”) with BioLexis, pursuant to which the Company exchanged 58,735 shares of voting Series A Convertible held by BioLexis for 58,735 shares of its newly created series of voting convertible preferred stock, voting Series A‑1 Convertible Preferred Stock, (the “Series A‑1”). Accordingly, all of the issued Series A Convertible have been retired and cancelled and may not be reissued as shares of such series in accordance with their terms. In connection with the entry into the Exchange Agreement, the Company and BioLexis amended the Investor Rights Agreement dated September 11, 2017, as amended, (the “Second Amendment to Investor Rights Agreement”) in order to provide the Investor certain registration and other rights with respect to the shares of Common Stock to be acquired upon conversion of the Series A‑1 issued pursuant to the Exchange Agreement. A total of 200,000 shares of Series A‑1 have been authorized for issuance under the Certificate of Designation of Series A‑1 Convertible Preferred Stock of the Company. The shares of Series A‑1 have a stated value of $100.00 per share and rank senior to all junior securities (as defined in the Certificate of Designation). The Series A‑1 accrue dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A‑1. The Series A‑1 is also entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of Common Stock or other securities. The initial conversion rate is subject to appropriate adjustment in the event of a stock split, stock dividend, combination, reclassification or other recapitalization affecting the Common Stock. The holders of the Series A‑1 have the right to vote on matters submitted to a vote of the Company’s stockholders on an as-converted basis, voting with the Company’s other stockholders as a single class. In addition, without the prior written consent of a majority of the outstanding shares of Series A‑1, the Company may not take certain actions, including amending its certificate of incorporation or bylaws, or issuing securities ranking pari passu or senior to the Series A‑1. During the years ended September 30, 2019 and 2018, the Company issued an additional 6,248 and 1,468 shares, respectively, of Series A‑1 to settle the related dividends that were due on a quarterly basis. The Company recognized a beneficial conversion charge of $61,365 and $70,662, respectively, during the years ended September 30, 2019 and 2018, which represents the in-the-money value of the conversion rate as of the date of issuance. At September 30, 2019, 66,451 shares of Series A-1 were convertible into 1,255,789 shares of common stock. The terms of the Series A‑1 distinguish between certain liquidation events (such as a voluntary or involuntary liquidation, dissolution or winding up of the Company) and “deemed” liquidation events (such as a sale of all or substantially all of the Company’s assets, various merger and reorganization transactions, being delisted from Nasdaq, and the occurrence of an event of default under the terms of the senior secured notes), in each case as defined in the Certificate of Designation. In the event of a liquidation (as defined in the Certificate of Designation), the liquidation preference payable equals the sum of (A) 550% of the Series A-1 stated value per share plus (B) an amount equal to (x) 550% of any accrued, but unpaid, preferred dividends (as defined in the Certificate of Designation) plus (y) any unpaid participating dividends (as defined in the Certificate of Designation). In the case of a deemed liquidation event (as defined in the Certificate of Designation), the multiplier is increased to 600%. The Series A‑1 is convertible at any time at the option of the holder based on the then applicable conversion rate. If conversion is in connection with a liquidation, the holder is entitled to receive 550% of the number of shares of common stock issuable based upon the then applicable conversion rate. In the event of a deemed liquidation event, the multiplier is increased to 600%. Additionally, the holder may irrevocably require the Company to redeem the Series A-1 in the event of a deemed liquidation event for the sum of (A) 600% of the Series A-1 stated value per share plus (B) an amount equal to (x) 600% of any accrued, but unpaid, preferred dividends plus (y) any unpaid participating dividends, although such redemption may not be made without the consent of the senior secured noteholders if such notes are outstanding at the time of any such redemption. The shares of Series A‑1 have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States without registration or an applicable exemption from the registration requirements of the Securities Act. The exchange of the Series A‑1 for the shares of Series A held by the Investor was made in reliance on Sections 3(a)(9) and 4(a)(2) under the Securities Act, without general solicitation or advertising.

Stock-Based Compensation

Stock-Based Compensation	12 Months Ended
	Sep. 30, 2019
Stock-Based Compensation
Stock-Based Compensation	12. Stock-Based Compensation 2011 Equity Incentive Plan The Company’s 2011 Equity Compensation Plan (the “2011 Plan”) provided for the Company to sell or issue restricted common stock, RSUs, performance-based awards (“PSUs”), cash-based awards or to grant stock options for the purchase of common stock to officers, employees, consultants and directors of the Company. The 2011 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board. The number of shares of common stock reserved for issuance under the 2011 Plan is 106,490. As of September 30, 2019, PSUs representing 16,131 shares of the Company’s common stock were outstanding under the 2011 Plan. In light of the December 2015 adoption of the 2015 Equity Incentive Plan, (the “2015 Plan”) no future awards under the 2011 Plan will be granted. 2015 Equity Incentive Plan In December 2015, the Company adopted the 2015 Plan. The 2015 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The aggregate number of shares of common stock authorized for issuance pursuant to the Company’s 2015 Plan is 2,869,598. As of September 30, 2019, 1,309,950 shares remained available for grant under the 2015 Plan. Stock options and RSUs granted under the Company's 2015 Plan generally vest over a period of two to four years from the date of grant and, in the case of stock options, have a term of 10 years. The Company recognizes the grant date fair value of each option and share of RSU over its vesting period. Year ended September 30, 2019 2018 Research and development $ 37,053 $ 19,450 General and administrative 1,276,282 1,966,420 $ 1,313,335 $ 1,985,870 Stock options The following table summarizes all of the Company’s stock option activity for the years ended September 30, 2018 and 2019: Weighted Average Weighted Remaining Number of Average Contractual Shares Exercise Price Term (Years) Balance at October 1, 2017 — $ — Granted 208,357 Forfeited (26,237) Balance at September 30, 2018 182,120 Granted 1,449,498 Expired (19,077) Forfeited (222,542) Balance at September 30, 2019 1,389,999 9.7 Vested and exercisable 172,405 8.6 Vested and expected to vest at September 30, 2019 1,389,999 $ 9.7 As of September 30, 2019, the aggregate intrinsic value of the stock options was zero. The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model, wherein expected volatility is based on historical volatility of the publicly traded common stock of a peer group of companies. The expected term calculation is based on the “simplified” method described in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment , and SAB No. 110, Share-Based Payment , since the simplified method provides a reasonable estimate in comparison to actual experience. The risk-free interest rate is based on the U.S. Treasury yield at the date of grant for an instrument with a maturity that is commensurate with the expected term of the stock options. The dividend yield is zero since the Company has never paid cash dividends on its common stock and has no present intention to pay cash dividends. Options granted under the 2015 Plan generally vest over two to four years and have a term of 10 years. The weighted average grant date fair value of the options awarded to employees for the years ended September 30, 2019 and 2018 was $2.86 and $4.48 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: Year ended September 30, 2019 2018 Risk-free interest rate 2.02% 2.80% Expected life (years) 6.14 6.00 Expected volatility 92.7% 71.0% Expected dividend yield — — As of September 30, 2019, there was $2,493,119 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 3.6 years. Performance-Based stock units The Company has issued PSUs, which generally have a ten -year life from the date of grant. Upon exercise, the PSU holder receives common stock or cash at the Company’s discretion. The following table summarizes the activity related to PSUs during the years ended September 30, 2019 and 2018: Weighted Average Remaining Number of Base Price Per Contractual PSUs PSU Term (Years) Balance at October 1, 2017 21,933 $ 50.16 Forfeitures (5,802) 51.44 Balance at September 30, 2018 16,131 49.99 Forfeitures (440) 50.60 Balance at September 30, 2019 15,691 49.97 4.7 Vested and exercisable at September 30, 2019 15,691 49.97 4.7 Vested and expected to vest at September 30, 2019 15,691 $ 49.97 4.7 Restricted stock units The Company has granted RSUs that generally vest over a period of two to four years from the date of grant. The following table summarizes the activity related to RSUs during the years ended September 30, 2019 and 2018: Weighted Number of Average Grant RSUs Date Fair Value Balance at October 1, 2017 117,485 $ 150.24 Granted 2,500 9.28 Vested and settled (105,361) 147.20 Forfeitures (6,986) 3.14 Balance at September 30, 2018 7,638 153.88 Vested and settled (4,069) Forfeitures (3,460) Balance at September 30, 2019 109 $ As of September 30, 2019, there was $1,021 of unamortized expense that will be recognized over a weighted-average period of 0.2 years.

Collaboration Arrangements

Collaboration Arrangements	12 Months Ended
	Sep. 30, 2019
Collaboration Arrangements
Collaboration Arrangements	13. Collaboration Arrangements During fourth quarter of fiscal year 2019, the Company substantially completed its efforts to outsource the commercial manufacturing and remaining development for the ONS-5010 program, resulting in the termination of the majority of manufacturing and development personnel and initiation of efforts to sell or transfer excess manufacturing, laboratory and related computer equipment no longer required for the development of ONS-5010 program. As a result, the Company no longer has the internal capability to support its inactive development programs for ONS-3010 (biosimilar for Humira) and ONS-1045 (biosimilar for Avastin) and does not intend to complete the development of these assets in the United States and other developed markets. All future development for the biosimilar programs, if any, will be completed by the Company's existing, or potential future, partners without further assistance from the Company. As a result, the Company recognized all remaining deferred revenues as of September 30, 2019 for each of its collaboration agreements. Huahai Agreement In May 2013, the Company entered into strategic license and collaboration arrangement with Zhejiang Huahai Pharmaceutical Co., Ltd (“Huahai”) under which the Company granted Huahai and its affiliates an exclusive license for the research, development, manufacture, use or sale of ONS‑3010 or ONS‑1045 in China, including, the People’s Republic of China, Hong Kong, Macau and Taiwan. In addition, the Company granted Huahai a right and license under the Selexis Technology agreement to establish a production process for the products in the agreed territory and to market the products in the agreed territory pursuant to the relevant terms and conditions of the Company’s commercial license agreement with Selexis. Under the terms of the arrangement, the Company has received $7,500,000 in upfront payments and milestones and received $8,500,000 in substantive milestones. The Company determined that the deliverables under the Huahai arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have a standalone value, the upfront milestones payments received had been deferred and were being recognized ratably on a straight line basis through December 2021, the expected date in which the research and development would be completed prior to the Company’s decision in the fourth quarter of fiscal 2019 to stop developing its biosimilar assts as described fully above. During years ended September 30, 2019 and 2018, the Company recognized $4,828,584 and $714,848, respectively, of deferred revenues. As of September 30, 2018, deferred revenue included in the Company’s consolidated balance sheet related to the Huahai arrangement was $2,323,254. IPCA License and Collaboration Agreement In August 2013, the Company entered into a strategic license agreement with IPCA Laboratories Limited and its affiliates (“IPCA”) under which the Company granted IPCA a license for the research, development, manufacture, use or sale of the ONS‑3010 and, by amendment in May 2014, the ONS‑1045 biosimilar product candidates with respect to India, Sri-Lanka, and Myanmar, and non-exclusive with respect to Nepal and Bhutan, or collectively, the agreed territory. In addition, the Company granted IPCA a right and license under the Selexis Technology to enable IPCA to establish an exclusive production process for the products in its agreed territory and to exclusively market the products in the agreed territory. The Company also agreed not to amend or terminate its rights under its commercial license agreement with Selexis without IPCA’s prior written consent. Pursuant to the agreement, the Company agreed to continue the non-clinical and clinical development of each of ONS‑3010 and ONS‑1045 and corresponding products around the world and to develop and commercialize such products through Phase 3 clinical trials and regulatory approval in the United States and European Union. These obligations continue until termination of the agreement or the individual development programs or upon final regulatory approval of the last product for such biosimilars in the United States or European Union. The Company agreed to provide IPCA with a pre-IND package as submitted to EMEA and FDA, as well as perform preclinical development and characterization of ONS‑3010 and ONS‑1045 so as to enable IPCA to file an IND to conduct clinical trials and to perform clinical trials. Under the terms of the agreement, the Company has received upfront and milestone payments of $2,400,000 and received $1,000,000 in regulatory milestone payments. In addition, the Company is eligible to receive royalties at a low double-digit percentage rate of annual net sales of products by IPCA and its affiliates in the agreed territory. For each of ONS‑3010 and ONS‑1045, IPCA agreed to fund a portion of the global costs associated with the Phase 3 clinical trials. The Company determined that the deliverables under the IPCA arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have standalone value, the upfront and milestones payments received had been deferred and were being recognized ratably on a straight line basis through December 2021 the expected date in which the research and development would be completed prior to the Company’s decision in the fourth quarter of fiscal 2019 to stop developing its biosimilar assts as described fully above. As of September 30, 2019, the Company has received an aggregate of $5.0 million of payments from IPCA under its various agreements. During each of the years ended September 30, 2019 and 2018, the Company recognized deferred revenues of $1,664,085 and $261,072, respectively. As of September 30, 2018, deferred revenue included in the Company’s consolidated balance sheets was $848,486. Liomont Agreement In June 2014, the Company entered into a strategic license agreement with Liomont, under which the Company granted Liomont and its affiliates an exclusive, sublicenseable license in Mexico for the research, development, manufacture, use or sale of the ONS‑3010 and ONS‑1045 biosimilar product candidates in Mexico. In addition, the Company granted Liomont a non-exclusive right and license under the Selexis Technology and related intellectual property to enable Liomont to distribute, market and commercialize the products in Mexico. The Company also agreed not to amend or terminate its rights under the commercial agreement with Selexis without Liomont’s prior written consent. Under the terms of the agreement, the Company has received upfront payments and milestone payments of $2,000,000 and received $1,000,000 in regulatory milestone payments. In addition, the Company is eligible to receive up to $2,000,000 in future substantive milestone payments. For each of ONS‑3010 and ONS‑1045, Liomont agreed to fund a portion of the global costs for Phase 3 clinical trials. The Company is eligible to receive tiered royalties at upper single digit to low double-digit percentage rates of annual net sales of products by Liomont and its affiliates in Mexico. The Company determined that the deliverables under the Liomont arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have standalone value, the upfront payments received had been deferred and were being recognized ratably on a straight-line basis through December 2021, the expected date in which the research and development would be completed prior to the Company’s decision in the fourth quarter of the year ended September 30, 2019 described fully above. As of September 30, 2019, the Company has received an aggregate of $3.0 million of upfront and milestone payments from Liomont. During the years ended September 30, 2019 and 2018, the Company recognized deferred revenue of $1,097,412 and $236,641, respectively. As of September 30, 2018, deferred revenue included in the Company’s consolidated balance sheets was $769,083. BioLexis Agreement In July 2017, the Company entered into a strategic licensing agreement with BioLexis, under which it granted BioLexis and its affiliates a perpetual, irrevocable, exclusives sublicensable license in the agreed territory for the research, development, manufacture, use or sale of the ONS‑1045 biosimilar product candidate in the agreed territory. The agreed territory includes all emerging markets, but specifically excludes major developed markets, such as the United States, Canada, Europe, Japan, Australia and New Zealand, and smaller markets where the Company has existing licensing arrangements, such as Mexico, greater China and India. The Company received an initial upfront payment from BioLexis of $1.25 million, and an additional $1.25 million upon meeting a notice and acknowledgment milestone. In September 2017 the Company and BioLexis superseded and replaced the strategic license agreement with a Joint Development and License Agreement (the “JDLA”) providing for the development and commercialization of the Company’s ONS‑3010 and ONS‑1045 biosimilar product candidates in the same geographic territories. In exchange for granting BioLexis a perpetual, irrevocable, exclusive, sublicensable license in the agreed territory for the research, development, manufacture, use or sale of the ONS‑3010 and ONS‑1045 biosimilar product candidates in the agreed territory, BioLexis made an additional payment of $2.5 million in connection with the JDLA. The Company may receive up to an additional $2.5 million milestone payments under the JDLA for each licensed product upon achievement of certain net profit thresholds. The parties agreed to share net profits based on sales of licensed products in the agreed territory, in proportions weighed in BioLexis’s favor, subject to adjustment as provided in the agreement. During the years ended September 30, 2019 and 2018, the Company recognized revenue of $556,042 and $1,874,999, respectively, under the BioLexis agreements. As of September 30, 2018, deferred revenue included in the Company’s consolidated balance sheet was $526,042.

Related-Party Transactions

Related-Party Transactions	12 Months Ended
	Sep. 30, 2019
Related-Party Transactions
Related-Party Transactions	14. Related-Party Transactions MTTR - Strategic Partnership Agreement (ONS-5010) In November 2018, the board of directors of the Company appointed Mr. Terry Dagnon as Chief Operating Officer, and Mr. Jeff Evanson as Chief Commercial Officer. Both Mr. Dagnon and Mr. Evanson are providing services to the Company pursuant to the February 2018 strategic partnership agreement with MTTR, LLC ("MTTR"). Mr. Dagnon and Mr. Evanson are both principals in MTTR. The Company will not be paying Mr. Dagnon or Mr. Evanson any direct compensation as consultants or as employees. Both Mr. Dagnon and Mr. Evanson are compensated directly by MTTR for services provided to the Company as the Company's Chief Operating Officer and Chief Commercial Officer, respectively, pursuant to the ONS-5010 Agreement. Mr. Dagnon and Mr. Evanson have also agreed to provide consulting services to an affiliate of BioLexis pursuant to a separate arrangement. In February 2018, the Company entered into a strategic partnership agreement with MTTR to advise on regulatory, clinical and commercial strategy and assist in obtaining approval of ONS-5010, the Company's bevacizumab therapeutic product candidate for ophthalmic indications. MTTR earned an aggregate $1,744,933 and $602,629 during the years ended September 30, 2019 and 2018, respectively, which includes monthly consulting fees and expense reimbursement. As of September 30, 2019 and 2018, amounts due to MTTR were $365,301 and $116,552, respectively, which amounts are included in accrued expenses in the accompanying consolidated balance sheets. Sonnet Biotherapeutics, Inc. - Contract Development and Manufacturing In May 2018, the Company negotiated a contract with Sonnet Biotherapeutics, Inc. (“Sonnet”) to provide contract development and manufacturing (“CDMO”) services. Additionally, in order to provide services to Sonnet and other potential CDMO customers, in November 2017, the Company acquired laboratory and office equipment from Sonnet with a value of $115,000 and during the year ended September 30, 2018, assumed leases of $201,000 for equipment necessary for the planned expansion of the Company’s development and manufacturing facilities. Such leases were personally guaranteed by Pankaj Mohan, Ph.D., the Company’s former chairman and chief executive officer, and former Class III director. In July 2019, the Company and Sonnet mutually agreed to terminate the contract. For other related party transactions during the years ended September 30, 2019 and 2018, refer to the Stockholder Notes (Note 7), Debt (Note 8) and the BioLexis Agreement (Note 13).

Income Taxes

Income Taxes	12 Months Ended
	Sep. 30, 2019
Income Taxes
Income Taxes	15. Income Taxes Income tax benefit for the years ended September 30, 2019 and 2018 consists of the following: Year ended September 30, 2019 2018 State tax $ (3,413,806) $ (3,148,216) Foreign tax 2,805 (500,000) $ (3,411,001) $ (3,648,216) During the years ended September 30, 2019 and 2018, the Company sold New Jersey State net operating losses in the amount of $31,168,800 and $38,470,278, and in the year ended September 30, 2019, unused R&D tax credits in the amount of $944,045, resulting in the recognition of income tax benefits of $3,415,806 and $3,150,716, respectively, recorded in the Company’s statement of operations. A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: Year ended September 30, 2019 2018 U.S. federal statutory rate (21.0) % (24.3) % State taxes, net of federal benefit (6.6) (6.9) Sale of New Jersey net operating losses (7.1) (7.1) Net operating loss 6.1 8.0 Change in tax rates — 66.6 Foreign withholding tax — (1.5) Permanent differences (0.2) (0.6) Foreign tax credits — 1.5 Research and development credit 0.8 (22.9) Change in valuation allowance 18.6 (23.7) Other 0.4 0.1 Effective income tax rate (9.0) % (10.8) % The tax effects of the temporary differences that gave rise to deferred taxes were as follows: September 30, 2019 2018 Deferred tax assets Net operating loss carryforwards $ 47,664,187 $ 39,532,689 Stock-based compensation 10,583,524 10,227,514 Deferred revenue — 1,264,069 Research and development credit carryforward 8,180,511 8,491,452 Foreign tax credits 2,357,309 2,357,309 Fixed assets — — Accruals and others 410,390 605,173 Gross deferred tax assets 69,195,921 62,478,206 Less: valuation allowance (68,967,686) (61,893,959) 228,235 584,247 Deferred tax liability: Fixed assets (228,235) (584,247) Net deferred tax assets $ — $ — As of September 30, 2019, the Company has approximately $202.7 million and $71.8 million of U.S. federal and New Jersey net operating losses that will begin to expire in 2030 and 2037, respectively. As of September 30, 2019, the Company has federal and state research and development tax credit carryforwards of $7.0 million and $1.2 million available, respectively, to reduce future tax liabilities which will begin to expire in 2032 and 2024, respectively. As of September 30, 2019, the Company has federal foreign tax credit (FTC) carryforwards of $2.4 million available to reduce future tax liabilities which will begin to expire starting in 2023, of which $1.9 million of the FTC carryforward is included in the balance of unrecognized tax benefits. Realization of the deferred tax asset is contingent on future taxable income and based upon the level of historical losses, management has concluded that the deferred tax asset does not meet the more-likely-than-not threshold for realizability. Accordingly, a full valuation allowance continues to be recorded against the Company’s deferred tax assets as of September 30, 2019 and 2018. The valuation allowance increased $7.1 million during the year ended September 30, 2019 and decreased $8.0 million during the year ended September 30, 2018. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely-than-not be realized. The determination as to whether the tax benefit will more-likely-than-not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes interest and penalties accrued on any unrecognized tax benefits within the provision for income taxes in its consolidated statements of operations. In December 2017, the Tax Cuts and Jobs Act of 2017 (the "Act") was signed into law making significant changes to the Internal Revenue Code. The corporate tax rate decreased from 34% to 21% effective for tax years beginning after December 31, 2017; for the fiscal year ended September 30, 2018, the federal tax rate is 24.3%; and for the fiscal year ended September 30, 2019, the federal tax rate is 21.0%. The Act also transitions international taxation from a worldwide system to a modified territorial system and includes base erosion prevention measures on non-U.S. earnings, which has the effect of subjecting certain earnings of the Company's foreign subsidiaries to U.S. taxation as global intangible low-taxed income. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Year ended September 30, 2019 2018 Balance at beginning of year $ 1,856,129 $ 2,352,129 Changes based on tax positions related to the current year 3,305 (496,000) Balance at end of year $ 1,859,434 $ 1,856,129 The Company does not anticipate material change in the unrecognized tax benefits in the next 12 months. These unrecognized tax benefits, if recognized, would affect the annual effective tax rate. The Company’s income tax returns for the years from 2011 through 2018 remain open for examination by the Internal Revenue Service as well as various states and municipalities. Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company’s net operating loss carryforwards may be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carry forward is subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there would be a reduction in the deferred tax assets with an offsetting reduction in the valuation allowance.

Basis of Presentation and Sum_2

Basis of Presentation and Summary of Significant Accounting Policies (Policies)	12 Months Ended
	Sep. 30, 2019
Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation	Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statement of operations as they occur.
Reverse stock-split	Reverse stock-split On March 15, 2019, the Company amended its amended and restated certificate of incorporation to implement a one-for-eight reverse stock split of its common stock. As a result of the reverse stock split, the Company adjusted the share amounts under its employee incentive plans, outstanding options, restricted stock units and common stock warrant agreements with third parties. The disclosure of common shares and per common share data in the accompanying consolidated financial statements and related notes reflect the reverse stock split for all periods presented.
Use of estimates	Use of estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary.
Fair value of financial instruments	Fair value of financial instruments At September 30, 2019 and 2018, the Company’s financial instruments included cash, accounts payable, accrued expenses, equipment loans, stockholder notes and senior secured debt. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments.
Property and equipment	Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the life of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations.
Long-lived assets	Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. The Company recognized an impairment loss of $11.3 million for the year ended September 30, 2019 which is described more fully in Note 5. There was no impairment charge recognized during the year ended September 30, 2018.
Stock-based compensation	Stock-based compensation The Company measures equity classified stock-based awards granted to employees and directors based on the estimated fair value on the date of grant and recognizes compensation expense of those awards, on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in Note 12. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant. Stock-based awards granted to consultants and non-employees are measured based on the fair value of the award on the date on which the related services are completed. Compensation expense is recognized over the period during which services are rendered by such consultants and non-employees until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option-pricing model. The Company accounts for forfeitures of stock option awards as they occur.
Revenue recognition	Revenue recognition On October 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) and changed its revenue recognition policies accordingly. The standard’s stated core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about: · Contracts with customers – including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations). · Significant judgments and changes in judgments – determining the timing of satisfaction of performance obligations (over time or at a point in time) and determining the transaction price and amounts allocated to performance obligations. · Certain assets  – assets recognized from the costs to obtain or fulfill a contract. The Company’s revenue is generated primarily through collaboration research and license agreements. The terms of these agreements generally contain multiple deliverables which may include (i) licenses, (ii) research and development activities, (iii) clinical manufacturing and, (iv) product supply. The payment terms of these agreements may include nonrefundable upfront fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. The Company typically receives upfront, nonrefundable payments when licensing its intellectual property. The Company’s arrangements fall under ASC 808, Collaborations (“ASC 808”). ASC 808 does not address recognition or measurement matters but prescribes that entities look to other GAAP by analogy, namely ASU 2014-09. As such, the Company completed an analysis of existing contracts with the Company’s collaboration partners and assessed the differences in accounting for such contracts under ASU 2014-09 compared with current revenue accounting standards. Under the ASU 2014-09, the Company treat substantive milestones as forms of variable consideration which is recognized over the estimated performance period. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. The Company adopted the new accounting standard utilizing the modified retrospective method, and, therefore, no adjustments were made to amounts in its prior period financial statements. The Company recorded the cumulative effect of adopting the standard as an adjustment to increase accumulated deficit by $3.6 million. During the fiscal year ended September 30, 2019, we would have recognized $4.5 million of collaboration revenues under revenue recognition guidance in effect during fiscal 2018 prior to the adoption of ASU 2014-09.
Incentive and tax receivables	Incentive and tax receivables The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable period. The Company’s estimate of the amount of cash refund it expects to receive related to the Australian research and development tax incentive program is included in prepaid and other current assets in the accompanying consolidated balance sheets. As of September 30, 2019, the Company’s estimate of the amount of cash refund it expects to receive in 2020 for 2019 eligible spending as part of this incentive program was $1.1 million. As of September 30, 2018, the Company had a receivable of $0.3 million which was received in 2019 as part of this incentive program. In addition, the Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in prepaid and other current assets in the accompanying consolidated balance sheet. As of September 30, 2019, and 2018, prepaid and other current assets included $0.1 million for refundable GST on expenses incurred with Australian vendors.
Research and development	Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the years ended September 30, 2019 and 2018, the Company recorded $1.2 million and $0.3 million, respectively, in its consolidated statements of operations related to the cash refund it expected to receive from the Australian research and development tax incentive program.
Income taxes	Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized.
Net loss per share	Net loss per share Basic net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2019 and 2018, as they would be antidilutive: September 30, 2019 2018 Series A‑1 convertible preferred stock 1,255,789 1,137,714 Convertible senior secured notes 767,605 — Convertible unsecured notes 149,573 — Performance-based stock units 15,691 16,131 Restricted stock units 109 7,638 Stock options 1,389,999 182,120 Common stock warrants 16,067,948 5,661,506
Recently issued accounting pronouncements	Recently issued accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASC 842”). The FASB issued subsequent amendments to the initial guidance in July 2018 with ASU 2018-10 and in August 2018 with ASU 2018-11. ASC 842 supersedes the current accounting for leases. The new standard requires lessees to record a right of use asset and a related liability for the rights and obligations associated with a lease, regardless of lease classification, and eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. The Company adopted the new standard on October 1, 2019 using a modified retrospective approach, the transition method that allows for application of the standard at the adoption date rather than at the beginning of the earliest comparative period presented in the financial statements. The Company also elected available practical expedients. While the Company is still finalizing its adoption procedures, the Company estimates the primary impact to the consolidated financial position upon adoption will be the recognition, on a discounted basis, of the minimum commitments under noncancelable operating leases on the consolidated balance sheets resulting in the recording of lease obligations for approximately $0.4 million. The adoption of the guidance will not impact the Company’s consolidated statements of operations or cash flows. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which removes and modifies some existing disclosure requirements and adds others. ASU 2018-13 modifies the disclosure requirements for fair value measurements and removes the requirement to disclose (1) the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, (2) the policy for timing of transfers between levels, and (3) the valuation processes for Level 3 fair value measurements. ASU 2018-13 requires disclosure of changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The ASU is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. Early adoption is permitted for any eliminated or modified disclosures upon issuance of this ASU. The Company is currently evaluating the impact of the adoption of this standard.

Basis of Presentation and Sum_3

Basis of Presentation and Summary of Significant Accounting Policies (Tables)	12 Months Ended
	Sep. 30, 2019
Basis of Presentation and Summary of Significant Accounting Policies
Schedule of dilutive securities excluded from the computation weighted-average shares	September 30, 2019 2018 Series A‑1 convertible preferred stock 1,255,789 1,137,714 Convertible senior secured notes 767,605 — Convertible unsecured notes 149,573 — Performance-based stock units 15,691 16,131 Restricted stock units 109 7,638 Stock options 1,389,999 182,120 Common stock warrants 16,067,948 5,661,506

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	12 Months Ended
	Sep. 30, 2019
Fair Value Measurements
Schedule of assets and liabilities measured at fair value on a recurring basis	September 30, 2019 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 255,734 September 30, 2018 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 1,227,225
Schedule of changes in the fair value of Level 3 valuation for the warrant liability	Balance at October 1, 2017 $ 2,274,954 Change in fair value (1,047,729) Balance at September 30, 2018 1,227,225 Senior note warrants modification 1,466,710 (i) Change in fair value (2,438,201) Balance at September 30, 2019 $ 255,734 (i)
Schedule of fair value of the warrant liability	September 30, 2019 2018 Risk-free interest rate 1.56% 2.90% Remaining contractual life of warrant 5.38 years 3.39 years Expected volatility 89% 82% Annual dividend yield 0% 0% Fair value of common stock $ 1.49 per share $ 7.84 per share

Property and Equipment, Net (Ta

Property and Equipment, Net (Tables)	12 Months Ended
	Sep. 30, 2019
Property and Equipment, Net
Schedule of property and equipment	September 30, 2019 2018 Laboratory equipment $ 1,067,351 $ 14,333,624 Leasehold improvements 160,086 10,095,100 Computer software and hardware — 483,807 Land and building 3,000,000 3,000,000 Construction in progress — 2,276,737 4,227,437 30,189,268 Less: accumulated depreciation and amortization (1,051,477) (11,699,292) $ 3,175,960 $ 18,489,976
Schedule of future minimum lease payments under capital leases	2020 $ 1,608,067 2021 1,506,592 2022 1,535,809 2023 1,564,027 2024 1,593,291 Thereafter 5,691,492 13,499,278 Less: amounts representing interest (9,941,198) Less: current portion (192,290) Capital lease obligations, excluding current portion $ 3,365,790

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Sep. 30, 2019
Accrued Expenses
Schedule of accrued expenses	September 30, 2019 2018 Compensation $ 919,394 $ 2,231,122 Severance and related costs 505,570 396,138 Research and development 1,692,040 1,065,169 Interest payable 934,145 1,991,044 Professional fees 419,216 313,585 Director fees — 59,122 Other accrued expenses 152,623 402,291 $ 4,622,988 $ 6,458,471

Stockholder Notes (Tables)

Stockholder Notes (Tables)	12 Months Ended
	Sep. 30, 2019
Stockholder Notes
Schedule of stockholder notes	September 30, 2019 2018 Restricted stock repurchase notes $ 800,000 $ 800,000 Common stock repurchase note 2,812,500 2,812,500 Working capital notes — 1,000,000 3,612,500 4,612,500 Less: current portion (3,612,500) (4,612,500) $ — $ —

Debt (Tables)

Debt (Tables)	12 Months Ended
	Sep. 30, 2019
Debt
Schedule of Senior Secured Notes debt	September 30, 2019 2018 Convertible senior secured notes $ 6,699,000 $ 13,500,000 Unamortized debt discount — (320,551) $ 6,699,000 $ 13,179,449
Schedule of senior secured note	September 30, 2019 2018 Unsecured notes $ 977,966 $ — Equipment loans 98,487 164,967 1,076,453 164,967 Less: current portion (1,026,168) (66,480) Long-term debt $ 50,285 $ 98,487
Schedule of future maturities of other indebtedness	2020 $ 1,026,168 2021 50,285 $ 1,076,453

Commitments (Tables)

Commitments (Tables)	12 Months Ended
	Sep. 30, 2019
Commitments
Schedule of future minimum rental payments in operating leases	Balance Balance Expensed / Cash September 30, October 1, 2018 Accrued Expense Payments 2019 Lease termination payments $ 3,850,081 $ 485,117 $ (425,750) $ 3,909,448 Balance Expensed / Balance October 1, 2017 Accrued Expense Cash Payments September 30, 2018 Lease termination payments $ — $ 4,187,696 $ (337,615) $ 3,850,081 Derecognition of assets and liabilities — (14,014) — — $ — $ 4,173,682 $ (337,615) $ 3,850,081
Schedule of future termination payment derecognized assets and liabilities associated with financing lease	Operating Leases 2020 $ 187,500 2021 195,000 $ 382,500

Stockholders' Equity (Deficit)

Stockholders' Equity (Deficit) (Tables)	12 Months Ended
	Sep. 30, 2019
Stockholders' Equity (Deficit)
Schedule of warrants outstanding	Shares of common stock issuable upon Expiration Date exercise of warrants Exercise Price November 11, 2019 99,935 $ July 12, 2020 68,250 $ February 18, 2022 416,666 $ (i) April 24, 2024 10,340,000 $ December 22, 2024 277,122 $ (ii) April 13, 2025 145,686 $ (ii) May 31, 2025 62,437 $ (ii) October 31, 2025 2,093,750 $ May 10, 2026 1,282,051 $ June 8, 2026 1,282,051 $ 16,067,948 (i) In January 2019, the Company reduced the exercise price of these warrants from $52.80 to $12.00 and further extended the exercise period from February 18, 2019 to February 18, 2022. (ii) In November 2018, the Company reduced the exercise price of the warrants issued in connection with its senior secured notes from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years.

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	12 Months Ended
	Sep. 30, 2019
Stock-Based Compensation
Schedule of stock-based compensation expense	Year ended September 30, 2019 2018 Research and development $ 37,053 $ 19,450 General and administrative 1,276,282 1,966,420 $ 1,313,335 $ 1,985,870
Schedule of options to purchase common stock of Company outstanding under 2015 Plan	Weighted Average Weighted Remaining Number of Average Contractual Shares Exercise Price Term (Years) Balance at October 1, 2017 — $ — Granted 208,357 Forfeited (26,237) Balance at September 30, 2018 182,120 Granted 1,449,498 Expired (19,077) Forfeited (222,542) Balance at September 30, 2019 1,389,999 9.7 Vested and exercisable 172,405 8.6 Vested and expected to vest at September 30, 2019 1,389,999 $ 9.7
Schedule of weighted-average assumptions used in option pricing model for stock options	Year ended September 30, 2019 2018 Risk-free interest rate 2.02% 2.80% Expected life (years) 6.14 6.00 Expected volatility 92.7% 71.0% Expected dividend yield — —
Schedule of performance-based stock units activity	Weighted Average Remaining Number of Base Price Per Contractual PSUs PSU Term (Years) Balance at October 1, 2017 21,933 $ 50.16 Forfeitures (5,802) 51.44 Balance at September 30, 2018 16,131 49.99 Forfeitures (440) 50.60 Balance at September 30, 2019 15,691 49.97 4.7 Vested and exercisable at September 30, 2019 15,691 49.97 4.7 Vested and expected to vest at September 30, 2019 15,691 $ 49.97 4.7
Schedule of restricted stock units activity	Weighted Number of Average Grant RSUs Date Fair Value Balance at October 1, 2017 117,485 $ 150.24 Granted 2,500 9.28 Vested and settled (105,361) 147.20 Forfeitures (6,986) 3.14 Balance at September 30, 2018 7,638 153.88 Vested and settled (4,069) Forfeitures (3,460) Balance at September 30, 2019 109 $

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Sep. 30, 2019
Income Taxes
Schedule of Income tax expense	Year ended September 30, 2019 2018 State tax $ (3,413,806) $ (3,148,216) Foreign tax 2,805 (500,000) $ (3,411,001) $ (3,648,216)
Schedule of reconciliation of income tax expense (benefit) at the statutory federal income tax rate	Year ended September 30, 2019 2018 U.S. federal statutory rate (21.0) % (24.3) % State taxes, net of federal benefit (6.6) (6.9) Sale of New Jersey net operating losses (7.1) (7.1) Net operating loss 6.1 8.0 Change in tax rates — 66.6 Foreign withholding tax — (1.5) Permanent differences (0.2) (0.6) Foreign tax credits — 1.5 Research and development credit 0.8 (22.9) Change in valuation allowance 18.6 (23.7) Other 0.4 0.1 Effective income tax rate (9.0) % (10.8) %
Schedule of deferred taxes	September 30, 2019 2018 Deferred tax assets Net operating loss carryforwards $ 47,664,187 $ 39,532,689 Stock-based compensation 10,583,524 10,227,514 Deferred revenue — 1,264,069 Research and development credit carryforward 8,180,511 8,491,452 Foreign tax credits 2,357,309 2,357,309 Fixed assets — — Accruals and others 410,390 605,173 Gross deferred tax assets 69,195,921 62,478,206 Less: valuation allowance (68,967,686) (61,893,959) 228,235 584,247 Deferred tax liability: Fixed assets (228,235) (584,247) Net deferred tax assets $ — $ —
Schedule of reconciliation of unrecognized tax benefits	Year ended September 30, 2019 2018 Balance at beginning of year $ 1,856,129 $ 2,352,129 Changes based on tax positions related to the current year 3,305 (496,000) Balance at end of year $ 1,859,434 $ 1,856,129

Liquidity (Details)

Liquidity (Details) - USD ($)	Dec. 11, 2019	Dec. 31, 2019	Sep. 30, 2019	Sep. 30, 2018
Liquidity [Line Items]
Accumulated deficit			$ (254,480,408)	$ (216,307,363)
Aggregate indebtedness			6,700,000
Notes payable to stockholders on due demand			1,000,000
Notes payable to stockholders on matures			3,600,000
Outstanding principal and accrued interest held			3,612,500	$ 4,612,500
Subsequent Event
Liquidity [Line Items]
Sale of unused net operating losses and research and development tax credits	$ 3,600,000
Proceeds from sale of net operating losses and research and development tax credits	$ 3,300,000
Stockholder Notes
Liquidity [Line Items]
Outstanding principal and accrued interest held			$ 1,000,000
Stockholder Notes | Subsequent Event
Liquidity [Line Items]
Outstanding principal and accrued interest held		$ 1,500,000
Common stock issued up on conversion of stockholder notes (in shares)		1,475,258

Basis of Presentation and Sum_4

Basis of Presentation and Summary of Significant Accounting Policies - Potentially dilutive securities (Details) - shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Series A-1 convertible preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	1,255,789	1,137,714
Performance-based stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	15,691	16,131
Restricted stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	109	7,638
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	1,389,999	182,120
Warrant
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	16,067,948	5,661,506
Convertible senior secured notes
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	767,605
Unsecured notes
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	149,573

Basis of Presentation and Sum_5

Basis of Presentation and Summary of Significant Accounting Policies - Additional information (Details) $ in Millions	12 Months Ended
	Sep. 30, 2019AUD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)	Feb. 29, 2016USD ($)
Basis of Presentation and Summary of Significant Accounting Policies
Estimated useful lives	3 to 10 years	3 to 10 years
Methods of depreciation and amortization	straight-line method	straight-line method
Annual aggregate revenues	$ 20
Estimate of the amount of cash refund eligible spending as part of this incentive program		$ 1,100,000
Cash refund receivable from Australian Taxation Office			$ 300,000
Lease obligations				$ 400,000
Refundable GST on expenses		100,000	100,000
Operations related to cash refund		1,200,000	300,000
Collaboration revenues under revenue recognition guidance		4,500,000
Cumulative effect of adoption of ASU 2014-09 (Topic 606)		(3,649,258)
Impairment charge		$ 11,270,110	$ 0

Fair Value Measurements (Detail

Fair Value Measurements (Details) - Fair value measurements recurring basis - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Level 1
Liabilities
Warrant liability	$ 0	$ 0
Level 2
Liabilities
Warrant liability	0	0
Level 3
Liabilities
Warrant liability	$ 255,734	$ 1,227,225

Fair Value Measurements - Chang

Fair Value Measurements - Changes in fair value (Details) - USD ($)		12 Months Ended
		Sep. 30, 2019	Sep. 30, 2018
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance at October 1, 2017		$ 1,227,225	$ 2,274,954
Senior note warrants modification	[1]	1,466,710
Change in fair value		(2,438,201)	(1,047,729)
Balance at September 30, 2019		$ 255,734	$ 1,227,225
[1]	In connection with the November 2018 private placement to BioLexis Pte. Ltd. (“BioLexis”), the Company reduced the exercise price of the warrants issued in connection with the senior secured notes (the “Senior Note Warrants”) from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. Such Senior Note Warrants now expire eight years from their initial exercise date.

Fair Value Measurements - Optio

Fair Value Measurements - Option pricing model (Details)	Sep. 30, 2019$ / shares	Sep. 30, 2018$ / shares
Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	1.56	2.90
Remaining contractual life of warrant
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Expected term	5 years 4 months 17 days	3 years 4 months 21 days
Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	89	82
Annual dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	0	0
Fair value of common stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value	$ 1.49	$ 7.84

Fair Value Measurements - Addit

Fair Value Measurements - Additional Information (Details) - $ / shares	1 Months Ended
	Nov. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Oct. 31, 2017
Fair Value Measurements
Exercise price per share | $ / shares	$ 24	$ 2.90	$ 0.08	$ 7.20
Reduced the exercise price of the warrants	$ 12
Extended term expiration of senior note warrants	3 years
Terms of warrant expiration	8 years

Property and Equipment, Net (De

Property and Equipment, Net (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 4,227,437	$ 30,189,268
Less: accumulated depreciation and amortization	(1,051,477)	(11,699,292)
Property and equipment, net	3,175,960	18,489,976
Laboratory equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	1,067,351	14,333,624
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property and equipment, gross	160,086	10,095,100
Computer software and hardware
Property, Plant and Equipment [Line Items]
Property and equipment, gross	0	483,807
Land and building
Property, Plant and Equipment [Line Items]
Property and equipment, gross	3,000,000	3,000,000
Construction in progress
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 0	$ 2,276,737

Property and Equipment, Net - F

Property and Equipment, Net - Future minimum lease payments (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Property, Plant and Equipment [Line Items]
Less: current portion	$ (192,290)	$ (520,794)
Capital lease obligations	3,365,790	$ 3,453,256
Laboratory equipment
Property, Plant and Equipment [Line Items]
2020	1,608,067
2021	1,506,592
2022	1,535,809
2023	1,564,027
2024	1,593,291
Thereafter	5,691,492
Total future minimum lease payments under capital leases	13,499,278
Less: amounts representing interest	(9,941,198)
Less: current portion	(192,290)
Capital lease obligations	$ 3,365,790

Property and Equipment, Net - A

Property and Equipment, Net - Additional information (Details) - USD ($)	1 Months Ended	12 Months Ended
	Feb. 28, 2018	Sep. 30, 2019	Sep. 30, 2018
Property, Plant and Equipment [Line Items]
Depreciation and amortization expense		$ 3,361,873	$ 3,054,351
Corporate office, interest rate		43.90%
Assets held for sale		$ 500,000
Impairment charge		11,270,110	0
Laboratory equipment
Property, Plant and Equipment [Line Items]
Laboratory equipment under capital leases		3,000,000	7,953,856
Accumulated depreciation related to leased equipment		475,000	1,619,741
Assets held for sale		500,000
Percentages lease occupying corporate facility	100.00%
Term of two renewal options	5 years
Lease obligation and corresponding building asset of estimated fair value	$ 3,000,000
Interest expense on capital leases		$ 1,425,913	$ 823,592
Laboratory equipment | Minimum
Property, Plant and Equipment [Line Items]
Term of capital leases		22 months
Capital leases interest rate		5.00%
Laboratory equipment | Maximum
Property, Plant and Equipment [Line Items]
Term of capital leases		36 months
Capital leases interest rate		19.40%
Construction in progress and laboratory equipment
Property, Plant and Equipment [Line Items]
Certain construction in progress and laboratory equipment written off		$ 1,913,798
Long-lived assets impaired		13,032,320
Long-lived assets fair value		$ 3,676,008

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Accrued Expenses
Compensation	$ 919,394	$ 2,231,122
Severance and related costs	505,570	396,138
Research and development	1,692,040	1,065,169
Interest payable	934,145	1,991,044
Professional fees	419,216	313,585
Director fees		59,122
Other accrued expenses	152,623	402,291
Accrued expenses, total	$ 4,622,988	$ 6,458,471

Stockholder Notes (Details)

Stockholder Notes (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Debt Instrument [Line Items]
Stockholder notes	$ 3,612,500	$ 4,612,500
Less: current portion	(3,612,500)	(4,612,500)
Long-tem stockholder notes		0
Restricted stock purchase notes
Debt Instrument [Line Items]
Stockholder notes	800,000	800,000
Common stock repurchase note
Debt Instrument [Line Items]
Stockholder notes	$ 2,812,500	2,812,500
Working capital notes
Debt Instrument [Line Items]
Stockholder notes		$ 1,000,000

Stockholder Notes - Additional

Stockholder Notes - Additional information (Details)	12 Months Ended
	Sep. 30, 2019USD ($)item$ / sharesshares	Sep. 30, 2018USD ($)$ / shares	Nov. 30, 2018$ / shares	Oct. 31, 2017$ / shares
Debt Instrument [Line Items]
Interest rate	12.00%
Original principal amount	$ 1,000,000
Interest expense related to the stockholder notes	105,357	$ 300,000
Stockholder notes	3,612,500	$ 4,612,500
Loss on extinguishment of debt	$ 183,554
Exercise price per share | $ / shares | $ / shares	$ 2.90	$ 0.08	$ 24	$ 7.20
Restricted stock purchase notes
Debt Instrument [Line Items]
Stockholder notes	$ 800,000	$ 800,000
Restricted stock purchase notes | Minimum
Debt Instrument [Line Items]
Interest rate	0.00%
Restricted stock purchase notes | Maximum
Debt Instrument [Line Items]
Interest rate	4.00%
Common stock repurchase note
Debt Instrument [Line Items]
Stockholder notes	$ 2,812,500	2,812,500
Working capital notes
Debt Instrument [Line Items]
Stockholder notes		$ 1,000,000
Exchange rate (per share) | $ / shares	$ 13.44
Exchange rate (as a percent)	95.00%
Number of lowest closing bid prices | item	2
Number of trading days | item	20
Carrying value of notes exchanged	$ 22,034
Accrued interest of notes exchanged	$ 457,966
Common stock issued up on conversion of stockholder notes (in shares) | shares	372,888
Weighted average exchange price (per share) | $ / shares	$ 1.29
Working capital notes | Minimum
Debt Instrument [Line Items]
Interest rate	0.00%
Working capital notes | Maximum
Debt Instrument [Line Items]
Interest rate	30.00%

Debt (Details)

Debt (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Debt Instrument [Line Items]
Senior secured notes	$ 6,699,000	$ 13,179,449
Convertible senior secured notes
Debt Instrument [Line Items]
Convertible senior secured notes	6,699,000	13,500,000
Unamortized debt discount	0	(320,551)
Senior secured notes	$ 6,699,000	$ 13,179,449

Debt - Outstanding debt (Detail

Debt - Outstanding debt (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Debt Instrument [Line Items]
Long-term Debt	$ 1,076,453	$ 164,967
Less: current portion	1,026,168	66,480
Long-term debt	50,285	98,487
Unsecured notes
Debt Instrument [Line Items]
Long-term Debt	977,966
Equipment loan
Debt Instrument [Line Items]
Long-term Debt	$ 98,487	$ 164,967

Debt - Future maturities (Detai

Debt - Future maturities (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Debt
2020	$ 1,026,168
2021	50,285
Total debt	$ 1,076,453	$ 164,967

Debt - Additional information (

Debt - Additional information (Details) - USD ($)	1 Months Ended		12 Months Ended
	Nov. 30, 2018	Oct. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Jun. 30, 2019	Apr. 30, 2019
Debt Instrument [Line Items]
Senior secured notes, principal amount			$ 1,000,000
Number of common stock called by warrants | shares			16,067,948	432
Interest rate			12.00%
Interest expense			$ 1,892,155	$ 1,997,231
Shares of common stock issuable upon exercise of warrants			16,067,948	432
Exercise price per share | $ / shares	$ 24	$ 7.20	$ 2.90	$ 0.08
Repayment of senior secured bank loans			$ 6,417,652	$ 127,736
Conversion of senior secured notes into Series B convertible preferred stock			401,967	14,359,816
Loss on extinguishment of debt			$ (607,240)	$ (1,252,353)
Series B convertible preferred stock
Debt Instrument [Line Items]
Conversion of Series A convertible preferred stock into common stock (in shares)		1,500,000
Accrued interest		$ 41,507
Conversion of Series B convertible preferred stock into common stock (in shares)				(1,500,000)
Purchase Agreement
Debt Instrument [Line Items]
Exercise price per share | $ / shares						$ 2.90
Equipment loan
Debt Instrument [Line Items]
Debt instrument, description of collateral			collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and former chief executive officer
Interest expense			$ 83,963	$ 27,660
Equipment loan | Minimum
Debt Instrument [Line Items]
Debt, interest rate			12.00%
Debt Instrument, term			1 year
Equipment loan | Maximum
Debt Instrument [Line Items]
Debt, interest rate			16.00%
Debt Instrument, term			5 years
Convertible senior secured notes
Debt Instrument [Line Items]
Carrying value of notes exchanged			$ 400,575
Accrued interest of notes exchanged			$ 1,393
Common stock issued up on conversion of stockholder notes (in shares)			50,394
Principal amount repaid			$ 6,400,000
Accrued interest repaid			1,300,000
Convertible senior secured notes | Private Placement | BioLexis
Debt Instrument [Line Items]
Exercise price per share | $ / shares	24
Reduced exercise price of the warrants | $ / shares	$ 12
Convertible senior secured notes | Series B convertible preferred stock
Debt Instrument [Line Items]
Conversion of senior secured notes into Series B convertible preferred stock		1,500,000
Loss on extinguishment of debt		$ 1,252,353
Convertible senior secured notes | Note and Warrant Purchase Agreement (the "NWPA")
Debt Instrument [Line Items]
Debt instrument, maturity date	Dec. 22, 2019
Convertible senior secured notes | Purchase and exchange agreement
Debt Instrument [Line Items]
Senior secured notes, principal amount	$ 13,500,000
Common stock price per share | $ / shares	$ 8.9539
Number of common stock called by warrants | shares	485,245
Additional debt discount	$ 1,500,000
Shares of common stock issuable upon exercise of warrants	485,245
Total amortization of the debt discount			1,314,321
Convertible senior secured notes | Third Amendment
Debt Instrument [Line Items]
Senior secured notes, principal amount					$ 6,700,000
Loss on extinguishment of debt			$ 423,686
Convertible senior secured notes | Minimum | Third Amendment
Debt Instrument [Line Items]
Interest rate					12.00%
Convertible senior secured notes | Maximum | Third Amendment
Debt Instrument [Line Items]
Interest rate					5.00%

Commitments (Details)

Commitments (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Lease Termination Obligation [Roll Forward]
Lease termination payments Beginning Balance	$ 3,850,081	$ 0
Lease termination payments expensed /accrued expense	485,117	4,187,696
Cash payments of lease termination	(425,750)	(337,615)
Lease termination payments Ending Balance	3,909,448	3,850,081
Derecognition of assets and liabilities Balance October 1, 2017	0	0
Derecognition of assets and liabilities expensed accrued expense		(14,014)
Cash payments of derecognition of assets and liabilities		0
Derecognition of assets and liabilities		0
Balance October 1, 2017	$ 3,850,081	0
Expensed accrued expense		4,173,682
Cash payments		(337,615)
Balance September 30, 2018		$ 3,850,081

Commitments - Future minimum pa

Commitments - Future minimum payments (Details)	Sep. 30, 2019USD ($)
Commitments
Operating Leases, 2020	$ 187,500
Operating Leases, 2021	195,000
Future minimum payments under noncancelable operating leases	$ 382,500

Commitments - Additional inform

Commitments - Additional information (Details) - USD ($)	1 Months Ended	12 Months Ended
	Aug. 31, 2018	Sep. 30, 2019	Sep. 30, 2018
Long-term Purchase Commitment [Line Items]
Rent expense under the leases		$ 1,139,714	$ 854,487
Defined contribution plan, maximum annual contributions per employee, percent		100.00%
Defined contribution plan, employer matching contribution, percent of match		100.00%
Description of defined contribution plan		The Company matches 100% of the first 3% of employee contributions
Expense related to matching contribution		$ 125,828	175,693
Consideration for termination of lease	$ 5,800,000
Amount of execution of termination agreement	287,615
Payment for lease per month	$ 50,000
Terms of payment for lease	30 months
Lease payment in any event	$ 4,000,000
Date of payment event before	Feb. 1, 2021
Security deposit	$ 174,250
Final payment of lease obligation	$ 4,000,000
Loss on lease termination			$ (4,173,682)
Derecognized assets and liabilities associated with financing lease		4,200,000
Technology license agreement
Long-term Purchase Commitment [Line Items]
Milestone payments amount		$ 353,600

Stockholders' Equity (Deficit_2

Stockholders' Equity (Deficit) (Details) - $ / shares	Sep. 30, 2019	Nov. 30, 2018	Sep. 30, 2018	Oct. 31, 2017
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	16,067,948		432
Exercise price per share	$ 2.90	$ 24	$ 0.08	$ 7.20
November 11, 2019
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	99,935
Exercise price per share	$ 0.08
July 12, 2020
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	68,250
Exercise price per share	$ 2.90
February 18, 2022
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	416,666
Exercise price per share	$ 12
April 24, 2024
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	10,340,000
Exercise price per share	$ 2.90
December 22, 2024
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	277,122
Exercise price per share	$ 12
April 13, 2025
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	145,686
Exercise price per share	$ 12
May 31, 2025
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	62,437
Exercise price per share	$ 12
October 31, 2025
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	2,093,750
Exercise price per share	$ 7.20
May 10, 2026
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	1,282,051
Exercise price per share	$ 7.80
June 8, 2026
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	1,282,051
Exercise price per share	$ 7.80

Stockholders' Equity (Deficit_3

Stockholders' Equity (Deficit) (Parentheticals) (Details) - $ / shares	1 Months Ended
	Nov. 30, 2019	Jan. 31, 2019	Sep. 30, 2019	Nov. 30, 2018	Sep. 30, 2018	Oct. 31, 2017
Class of Warrant or Right [Line Items]
Exercise price per share | $ / shares			$ 2.90	$ 24	$ 0.08	$ 7.20
Series A common stock warrants
Class of Warrant or Right [Line Items]
Exercise price of warrants issued for common stock		$ 52.80
Reduced Exercise Price Of Warrants		$ 12
Senior note warrants issued with senior secured notes
Class of Warrant or Right [Line Items]
Exercise price of warrants issued for common stock	$ 24
Reduced Exercise Price Of Warrants	$ 12
Class Of Warrant Or Right Term Of Warrant	3 years

Stockholders' Equity (Deficit_4

Stockholders' Equity (Deficit) - Common stock (Details) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	12 Months Ended
	Apr. 30, 2019	Sep. 30, 2019	Sep. 30, 2018	Nov. 30, 2018	Oct. 31, 2017
Stockholders Equity [Line Items]
Number of common stock called by warrants		16,067,948	432
Exercise price per share | $ / shares		$ 2.90	$ 0.08	$ 24	$ 7.20
Stock Issued During Period, Shares, New Issues		2,680,390
Net cash proceeds		$ 19.8
Purchase Agreement
Stockholders Equity [Line Items]
Exercise price per share | $ / shares	$ 2.90
Net cash proceeds	$ 26.2
Common stock warrants | Purchase Agreement
Stockholders Equity [Line Items]
Number of common stock called by warrants	10,340,000
BioLexis | Private Placement
Stockholders Equity [Line Items]
Gross cash proceeds		$ 20
Common stock repurchase note
Stockholders Equity [Line Items]
Number of shares issued upon vesting of restricted stock units (in shares)		4,069	105,361
Stock Issued During Period, Shares, New Issues		10,340,000	1,594,345
Common stock repurchase note | Purchase Agreement
Stockholders Equity [Line Items]
Number of common stock called by warrants		10,273,558
Number of common stock for private placement	10,340,000
Common stock repurchase note | 15-month warrants | Purchase Agreement
Stockholders Equity [Line Items]
Term of warrant	15 years
Warrant
Stockholders Equity [Line Items]
Number of warrant exercised		10,270,250
Term of warrant	5 years
Stock Issued During Period, Shares, New Issues		6,134,763
Warrant | Purchase Agreement
Stockholders Equity [Line Items]
Proceeds from issuance of warrants	$ 10,340,000

Stockholders' Equity (Deficit_5

Stockholders' Equity (Deficit) - Common stock warrants (Details) - $ / shares	Sep. 30, 2019	Nov. 30, 2018	Sep. 30, 2018	Oct. 31, 2017
Stockholders' Equity (Deficit)
Number of common stock called by warrants | shares	16,067,948		432
Exercise price per share | $ / shares	$ 2.90	$ 24	$ 0.08	$ 7.20

Convertible Preferred Stock (De

Convertible Preferred Stock (Details) - USD ($)	1 Months Ended			12 Months Ended
	Jun. 30, 2018	Dec. 31, 2017	Oct. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2017	Apr. 30, 2019	Nov. 30, 2018	Sep. 07, 2017
Convertible Preferred Stock [Line Items]
Number of share issued				2,680,390
Beneficial conversion charge				$ 61,365	$ 16,022,963
Sale of Series A convertible preferred stock and common stock warrants, net of costs				$ 26,156,503	$ 6,382,181
Convertible preferred stock, shares issued upon conversion				1,255,789
Exercise price per share | $ / shares			$ 7.20	$ 2.90	$ 0.08			$ 24
Common stock repurchase note
Convertible Preferred Stock [Line Items]
Number of share issued				10,340,000	1,594,345
Sale of Series A convertible preferred stock and common stock warrants, net of costs				$ 103,400
Conversion of senior secured notes into Series B convertible preferred stock (in shares)				50,394	3,946,577
Series A convertible preferred stock
Convertible Preferred Stock [Line Items]
Number of share issued					217,372
Beneficial conversion charge					$ 597,255
Sale of Series A convertible preferred stock and common stock warrants, net of costs					$ 14,265,861
Conversion of senior secured notes into Series B convertible preferred stock (in shares)					(208,836)
Series A Convertible Preferred Stock issued to settle dividends					17,571
BioLexis | Series A convertible preferred stock
Convertible Preferred Stock [Line Items]
Conversion of senior secured notes into Series B convertible preferred stock (in shares)	208,836
BioLexis | Series A convertible preferred stock | Common stock repurchase note
Convertible Preferred Stock [Line Items]
Convertible preferred stock, shares issued upon conversion	3,946,577
Purchase Agreement
Convertible Preferred Stock [Line Items]
Exercise price per share | $ / shares							$ 2.90
Private Placement | Purchase Agreement | BioLexis | Common stock repurchase note
Convertible Preferred Stock [Line Items]
Stock and warrant issued to acquire shares of common stock						2,093,750
Convertible preferred stock, shares issued upon conversion				4,724,493
Conversion rate per share				$ 5.28
Closing price		$ 10.08							$ 7.20
Private Placement | Purchase Agreement | BioLexis | Series A convertible preferred stock
Convertible Preferred Stock [Line Items]
Number of share issued						32,628
Sale of Series A convertible preferred stock and common stock warrants, net of costs						$ 3,262,800
Dividend rate		10.00%
Private Placement | Purchase Agreement | BioLexis | Series A Convertible and BioLexis Warrants
Convertible Preferred Stock [Line Items]
Proceeds from issuance of private placement						$ 25,000,000
Number of share issued						217,372
Beneficial conversion charge			$ 15,355,019
Sale of Series A convertible preferred stock and common stock warrants, net of costs						$ 21,737,200
Terms of warrant			8 years
Series A Convertible Preferred Stock issued to settle dividends					17,571

Convertible Preferred Stock - S

Convertible Preferred Stock - Series A 1 Convertible Preferred Stock - Additional information (Details) - USD ($)	1 Months Ended	12 Months Ended
	Jul. 31, 2018	Sep. 30, 2019	Sep. 30, 2018
Convertible Preferred Stock [Line Items]
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)		2,680,390
Convertible preferred stock, shares issued upon conversion		1,255,789
Shares available for conversion		66,451
Recognition Of Beneficial Conversion Feature Upon Issuance Of Convertible Preferred Stock		$ 61,365	$ 16,022,963
Series A convertible preferred stock
Convertible Preferred Stock [Line Items]
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)			217,372
Series A Convertible Preferred Stock issued to settle dividends			17,571
Recognition Of Beneficial Conversion Feature Upon Issuance Of Convertible Preferred Stock			$ 597,255
Series A-1 convertible Preferred Stock
Convertible Preferred Stock [Line Items]
Series A Convertible Preferred Stock issued to settle dividends		6,248
Recognition Of Beneficial Conversion Feature Upon Issuance Of Convertible Preferred Stock		$ 61,365	$ 70,662
Exchange agreement | BioLexis | Series A convertible preferred stock
Convertible Preferred Stock [Line Items]
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)	58,735
Exchange agreement | BioLexis | Series A-1 convertible Preferred Stock
Convertible Preferred Stock [Line Items]
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)	58,735
Series A-1 authorized for issuance		200,000
Shares Issued, Price Per Share		$ 100
Preferred Stock, Dividend Rate, Percentage		10.00%
Liquidation preference description		liquidation preference payable equals the sum of (A) 550% of the Series A-1 stated value per share plus (B) an amount equal to (x) 550% of any accrued, but unpaid, preferred dividends (as defined in the Certificate of Designation) plus (y) any unpaid participating dividends (as defined in the Certificate of Designation). In the case of a deemed liquidation event (as defined in the Certificate of Designation), the multiplier is increased to 600%
Percentage of stated value per share of preferred stock liquidation preference payable		550.00%
Percentage of accrued but unpaid preferred dividends		550.00%
Percentage increase in multiplier in case of deemed liquidation		600.00%
Deemed liquidation event description		Additionally, the holder may irrevocably require the Company to redeem the Series A-1 in the event of a deemed liquidation event for the sum of (A) 600% of the Series A-1 stated value per share plus (B) an amount equal to (x) 600% of any accrued, but unpaid, preferred dividends plus (y) any unpaid participating dividends, although such redemption may not be made without the consent of the senior secured noteholders if such notes are outstanding at the time of any such redemption

Stock-Based Compensation (Detai

Stock-Based Compensation (Details) - 2015 Equity Incentive Plan - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,313,335	$ 1,985,870
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	37,053	19,450
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,276,282	$ 1,966,420

Stock-Based Compensation - Stoc

Stock-Based Compensation - Stock option activity (Details) - $ / shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Number of Shares
Beginning Balance	182,120	0
Granted	1,449,498	208,357
Expired	(19,077)
Forfeited	(222,542)	(26,237)
Ending Balance	1,389,999	182,120
Vested and exercisable	172,405
Vested and expected to vest at September 30, 2019	1,389,999
Weighted Average Exercise Price
Beginning Balance	$ 6.96	$ 0
Granted	3.80	7.19
Expired	7.86
Forfeited	8.34	8.80
Ending Balance	3.43	$ 6.96
Vested and exercisable	7.19
Vested and expected to vest at September 30, 2019	$ 3.43
Weighted Average Remaining Contractual Term (Years)
Balance at December 31, 2019	9 years 8 months 12 days
Vested and exercisable	8 years 7 months 6 days
Vested and expected to vest at September 30, 2019	9 years 8 months 12 days

Stock-Based Compensation - Weig

Stock-Based Compensation - Weighted-average assumptions (Details)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Stock-Based Compensation
Risk-free interest rate	2.02%	2.80%
Expected life (years)	6 years 1 month 21 days	6 years
Expected volatility	92.70%	71.00%
Expected dividend yield	0.00%	0.00%

Stock-Based Compensation - Perf

Stock-Based Compensation - Performance-Based stock units (Details) - Performance-based stock units - $ / shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Number of PSUs
Beginning Balance	16,131	21,933
Forfeitures	440	5,802
Ending Balance	15,691	16,131
Vested and exercisable at September 30, 2019	15,691
Vested and expected to vest at September 30, 2019	15,691
Weighted Average Base Price Per Unit
Beginning Balance	$ 49.99	$ 50.16
Forfeitures	50.60	51.44
Ending Balance	49.97	$ 49.99
Vested and exercisable at September 30, 2019	49.97
Vested and expected to vest at September 30, 2019	$ 49.97
Weighted Average Remaining Contractual Term (Years)
Balance at September 30, 2019	4 years 8 months 12 days
Vested and exercisable at September 30, 2019	4 years 8 months 12 days
Vested and expected to vest at September 30, 2019	4 years 8 months 12 days

Stock-Based Compensation - Rest

Stock-Based Compensation - Restricted stock units (Details) - Restricted stock units - $ / shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Number of RSUs
Beginning Balance	7,638	117,485
Granted		2,500
Vested and settled	(4,069)	(105,361)
Forfeitures	(3,460)	(6,986)
Ending Balance	109	7,638
Weighted Average Grant Date Fair Value
Beginning Balance	$ 153.88	$ 150.24
Granted		9.28
Vested and settled	227.57	147.20
Forfeitures	69.06	3.14
Ending Balance	$ 96	$ 153.88

Stock-Based Compensation - 2011

Stock-Based Compensation - 2011 Equity Incentive Plan - Additional information (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, shares outstanding	28,609,995	9,027,491
Accrued directors fees settled in fully vested stock options	$ 49,121
2015 Equity Incentive Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares of common stock reserved for issuance	2,869,598
Number of shares available for grant	1,309,950
Vesting term	P10Y
2011 Equity Compensation Plan (the "2011 Plan") | Officers, Employees, Consultants and Directors
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares of common stock reserved for issuance	106,490
Common stock, shares outstanding	16,131

Stock-Based Compensation - St_2

Stock-Based Compensation - Stock options - Additional information (Details) - Stock options - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average grant date fair value of the options awarded to employees	$ 2.86	$ 4.48
Vesting term	10 years
Aggregate intrinsic value	$ 0
Unrecognized compensation expense	$ 2,493,119
Weighted average period of unrecognized compensation expense that is expected to be recognized	3 years 7 months 6 days
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	2 years
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	4 years

Stock-Based Compensation - Pe_2

Stock-Based Compensation - Performance-Based stock units - Additional information (Details)	12 Months Ended
	Sep. 30, 2019USD ($)
Performance-based stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of PSUs	10 years
Restricted stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unamortized expense	$ 1,021
Weighted-average period for recognition of unamortized expense	2 months 12 days

Collaboration Arrangements (Det

Collaboration Arrangements (Details) - USD ($)	1 Months Ended				12 Months Ended
	Jul. 31, 2017	Jun. 30, 2014	Aug. 31, 2013	May 31, 2013	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2017
Huahai Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Revenue reorganization deferred revenue					$ 4,828,584	$ 714,848
Deferred revenue						2,323,254
Huahai Agreement | Substantive milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received				$ 8,500,000
Huahai Agreement | Non-substantive milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received				$ 7,500,000
IPCA License and Collaboration Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received					5,000,000
Revenue reorganization deferred revenue					1,664,085	261,072
Deferred revenue						848,486
IPCA License and Collaboration Agreement | Substantive milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received			$ 1,000,000
IPCA License and Collaboration Agreement | Non-substantive milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received			$ 2,400,000
Liomont agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received		$ 1,000,000
Revenue reorganization deferred revenue					1,097,412	236,641
Deferred revenue						769,083
Liomont agreement | Substantive milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received		2,000,000			3,000,000
Liomont agreement | Non-substantive milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received		$ 2,000,000
BioLexis Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment received	$ 1,250,000						$ 2,500,000
Revenue reorganization deferred revenue					$ 556,042	1,874,999
Deferred revenue						$ 526,042
Additional milestone payments received	$ 1,250,000						$ 2,500,000

Related-Party Transactions (Det

Related-Party Transactions (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Nov. 30, 2017
Related Party Transaction [Line Items]
Acquired additional laboratory and office equipment	$ 437,307	$ 2,781,125
Sonnet Biotherapeutics, Inc. ("Sonnet")
Related Party Transaction [Line Items]
Laboratory equipment under capital leases			$ 115,000
Acquired additional laboratory and office equipment		201,000
Strategic partnership agreement | MTTR, LLC ("MTTR")
Related Party Transaction [Line Items]
Revenue from consulting fees and expense reimbursement	1,744,933	602,629
Strategic partnership agreement | MTTR, LLC ("MTTR") | Accrued expenses
Related Party Transaction [Line Items]
Amounts due to related party	$ 365,301	$ 116,552

Income Taxes (Details)

Income Taxes (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Income Taxes
State tax	$ (3,413,806)	$ (3,148,216)
Foreign tax	2,805	(500,000)
Income tax benefit	$ (3,411,001)	$ (3,648,216)

Income Taxes - Reconciliation o

Income Taxes - Reconciliation of income tax expense (benefit) (Details)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Income Taxes
U.S. federal statutory rate	(21.00%)	(24.30%)
State taxes, net of federal benefit	(6.60%)	(6.90%)
Sale of New Jersey net operating losses	(7.10%)	(7.10%)
Net operating loss	6.10%	8.00%
Change in tax rates		66.60%
Foreign withholding tax		(1.50%)
Permanent differences	(0.20%)	(0.60%)
Foreign tax credits		1.50%
Research and development credit	0.80%	(22.90%)
Change in valuation allowance	18.60%	(23.70%)
Other	0.40%	0.10%
Effective income tax rate	(9.00%)	(10.80%)

Income Taxes - Tax effects (Det

Income Taxes - Tax effects (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Deferred tax assets
Net operating loss carryforwards	$ 47,664,187	$ 39,532,689
Stock-based compensation	10,583,524	10,227,514
Deferred revenue		1,264,069
Research and development credit carryforward	8,180,511	8,491,452
Foreign tax credits	2,357,309	2,357,309
Accruals and others	410,390	605,173
Gross deferred tax assets	69,195,921	62,478,206
Less: valuation allowance	(68,967,686)	(61,893,959)
Deferred tax assets net of valuation allowance	228,235	584,247
Deferred tax liability:
Fixed assets	$ (228,235)	(584,247)
Net deferred tax assets		$ 0

Income Taxes - Unrecognized tax

Income Taxes - Unrecognized tax benefits (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward]
Balance at beginning of year	$ 1,856,129	$ 2,352,129
Changes based on tax positions related to the current year	3,305	(496,000)
Balance at end of year	$ 1,859,434	$ 1,856,129

Income Taxes - Additional infor

Income Taxes - Additional information (Details) - USD ($)	1 Months Ended	12 Months Ended
	Dec. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2017
Operating Loss Carryforwards [Line Items]
Research and development tax credit carryforwards		$ 8,180,511	$ 8,491,452
Foreign tax credit carryforwards		2,357,309	2,357,309
Unrecognized tax benefits		1,859,434	1,856,129	$ 2,352,129
Increase (decrease) in valuation allowance		(7,100,000)	8,000,000
Recognition of income tax benefits		$ (3,411,001)	$ (3,648,216)
Percentage of decrease in corporate tax rate	34.00%	21.00%
U.S. federal statutory rate		(21.00%)	(24.30%)
Decrease in deferred tax assets			$ (24,300,000)
New Jersey
Operating Loss Carryforwards [Line Items]
Net operating losses		$ 31,168,800	38,470,278
Research and development tax credit carryforwards		944,045
Recognition of income tax benefits		3,415,806	$ 3,150,716
New Jersey net operating loss		71,800,000
Federal
Operating Loss Carryforwards [Line Items]
Research and development tax credit carryforwards		7,000,000
Foreign tax credit carryforwards		2,400,000
Federal net operating loss		202,700,000
State
Operating Loss Carryforwards [Line Items]
Research and development tax credit carryforwards		$ 1,200,000